Tag Archives: FDA

FDA Approves Combination Of Ezetimibe And Atorvastatin Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , , ,

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin.

Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a once-daily tablet combining 10 mg of ezetimibe with either 10, 20, 40, or 80 mg of atorvastatin. In clinical trials Liptruzet lowered LDL cholesterol from 53% to 61%, depending on dosage.

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Click here to read the full post on Forbes.

 

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Danish Study Finds No Increased CV Risk With Azithromycin In General Population Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , ,

A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published  in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls who took no antibiotics and with matched controls who took penicillin V for similar indications.

Although there was a significant increase in the risk of death from cardiovascular causes in people taking azithromycin compared with people taking no antibiotics (RR 2.85, CI 1.13 – 7.24), there was no increase in risk when compared to people taking penicillin V (RR 0.93, CI 0.56 to 1.55). The findings, write the authors, indicate “that the increased risk that was observed in the comparison with no antibiotic use was entirely attributable to the risk of death associated with acute infection (or some other adverse health characteristic in persons receiving antibiotic treatment, as compared with those not treated with antibiotics) rather than with its treatment.”

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Click here to read the full story on Forbes.

Anticoagulation Update: New Agent For Urgent Anticoagulation Reversal, Pradaxa Label Revised 1

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , ,

Here are two small but important changes in the anticoagulation field:

FDA approves new product for urgent reversal of anticoagulation. 

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Pradaxa label gains boxed warning.

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Click here to read the full story on Forbes.

 

English: Logo of the .

 

The FDA, Surrogate Endpoints, And Blood Pressure Drugs Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , ,

In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels– the surrogate endpoint– serious questions emerged about the cardiovascular safety of the drug, eventually leading to its near withdrawal from the market in the US (and full withdrawal in Europe). Questions have also been raised about the long term health effects of drugs targeting a specific endpoint– including cholesterol and other lipids, blood glucose, weight loss, and blood pressure.

Despite what some believe is a long-term trend against the use of surrogate endpoints, the FDA is actually seeking to make it easier for manufacturers of one therapeutic category, antihypertensives, to claim cardiovascular benefit for their drugs despite the absence of evidence to support most of these drugs.

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Although the actual changes proposed by the FDA are small, I thought the issue bore further exploration. I first spoke with Norman Stockbridge, the director of the Division of Cardiovascular and Renal Products (DCaRP) in the Office of Drug Evaluation 1 at the FDA. I then asked Harlan Krumholz, Sanjay Kaul, and Franz Messerli and Sripal Bangalore to comment on this topic.

Click here to read the full article on Forbes.

Harlan Krumholz

Sanjay Kaul

FDA Schedules Another 2 Day Avandia Advisory Panel Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  ”discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.”

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Click here to read the full story on Forbes.

 

Recording vinyl to CD

 

Partial Rosiglitazone/RECORD Chronology

Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension Reply

by • People, Places & Events, Policy & Ethics • Tags: , , , , ,

For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA.

“We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner,” said the company’s chairman and CEO.

Treprostinil is a prostacyclin vasodilator that is already approved for the treatment of PAH in an injectable form (Remodulin) and in an inhalable form (Tyvaso). The FDA initially rejected the NDA for the drug last October.

 

CHMP And FDA Diverge On Mipomersen And Rivaroxaban Reply

by • Heart Rhythms, People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

The US FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected– for the second time– an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the same indication. In contrast, although the FDA recently approved the new cholesterol-lowering agent mipomersen (Kynamro, Isis and Genzyme), CHMP, after reviewing its previous negative position, reaffirmed today that it would not recommend approval of the drug in Europe.

Click here to read the full post on Forbes.

 

European Medicines Agency

 

FDA Panel Gives Tepid Endorsement To Abbott’s MitraClip Reply

by • Uncategorized • Tags: , , , , ,

The FDA’s Circulatory System Devices advisory panel today gave a tepid endorsement to Abbott Laboratories’ MitraClip device. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who  have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR.

At the end of the day, after a long and torturous discussion, the panel voted 5-3 in favor of the device, saying that the benefits outweighed the risks. The panel agreed unanimously that the device was safe (8-0) but by a narrow margin (5-4) said there was not a “reasonable assurance” that it was effective. The panel struggled over how to use the available data to identify patient groups that could benefit from the device.

Click here to read the full story on Forbes.

 

Mitraclip

Vena Cava Filters: Little Evidence And Wide Variation In Use Reply

by • Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , ,

Despite the absence of any evidence demonstrating benefit or showing how best to use them, vena cava filters (VCF) are used in most hospitals. Now a new study published in JAMA Internal Medicine suggests that this same lack of evidence results in an extremely broad rate of use in different hospitals. An accompanying viewpoint raises the question: “how could a medical device be so well accepted without any evidence of efficacy?”

Researchers conducted a retrospective observational study that compared the frequency of VCF use in 236 California hospitals by analyzing data from 130,643 acute VTE hospitalizations over four years. Overall, the rate of VCF placement was 14.95%, but there was a very broad variation in the percentage of acute VTE cases in which a VCF was placed, from 0% to 38.96%. The authors said that this finding places VCF “among surgical procedures with the greatest variation in geographic studies in the United States.” Even after adjusting for differences in patient populations between hospitals, the variation between hospitals remained significant.

Click here to read the full story on Forbes.

English: Taken by user:BozMo URL at http://cat...

English: Taken by user:BozMo URL at http://catesfamily.org.uk Picture of used inferior vena cava filter, showing the hook at top for removal via Jugular Vein, the umbrella structure and the leg spikes to fix in place. (Photo credit: Wikipedia)

FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran 1

by • Heart Rhythms, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine.

“We believe that the large number of reported cases of bleeding associated with dabigatran provides a salient example of stimulated reporting,” write Mary Ross Southworth, Marsha Reichman, and Ellis Unger. “In this case, such reporting provided a distorted estimate of the comparative bleeding rates associated with dabigatran and warfarin in clinical practice.”

Click here to read the full story on Forbes.

 

FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto) Reply

by • MI/ACS, Policy & Ethics • Tags: , , , , , ,

For the second time the FDA has turned down the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary syndrome (ACS).

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In a new press release issues on Monday afternoon, the company restated its confidence “in the robustness and results of the ATLAS ACS 2 TIMI 51 trial.” Criticism of ATLAS from the FDA and the advisory panel members had focused on missing data from the ATLAS trial. In today’s press release J&J provided more information about its efforts to address this question:

Click here for the complete story on Forbes.

FDA Issues Warning Letter To CoreValve Investigator Reply

by • Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , , , , , ,

The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer.

The subject of the FDA warning is Michael Ring, one of the two principal investigators of the CoreValve trial at the Providence Sacred Heart Medical Center site in Spokane, WA.

Click here to read the full story on Forbes. (Updated to include an additional comment from Dr. Ring.)

English: A warning sign with an exclamation mark

FDA Approves Second Generation MRI-Friendly Pacemaker System Reply

by • Heart Rhythms • Tags: , , ,

Medtronic announced today that the FDA had approved its Advisa DR MRI SureScan, a next generation pacemaker system specifically designed and tested for use with MRI scanners. The system, which Medtronic said would be launched immediately, includes the Advisa MRI device and two CapSureFix MRI SureScan leads.

 Click here to read the full post on Forbes.

Medtronic Advisa

ACC And STS Break New Ground To Test TAVR For Unapproved Uses Reply

by • Interventional Cardiology & Surgery • Tags: , , , , , , , , , ,

In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and hope to gain an IDE for at least two more trials. The news was first reported by The Gray Sheet (subscription required) on February 8.

The new development represents a significant enlargement of the TVT registry, already run by the ACC and STS, which tracks all TAVR usage in the US.

Click here to read the entire post on Forbes.

ACC STS TVT logo

Seeking Cardiovascular Safety Data, FDA Blocks Approval Of Novo Nordisk’s Long-Acting Insulin Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee also unanimously recommended that the company be required to perform a cardiovascular outcomes trial.

Click here to read the complete article on Forbes.

 

 

 

Popular Antidepressants May Put Patients At Risk For Serious Arrhythmias 1

by • Uncategorized • Tags: , , , , ,

In August 2011 the FDA issued a safety communication recommending that the extremely popular antidepressant citalopram (Celexa) not be used at doses greater than 40 mg/day because of a potential increased risk for serious cardiac arrhythmias associated with prolongation of the QT interval. Now a study published in BMJ lends support to this warning and suggests that other antidepressants may also prolong the QT interval.

Click here to read the complete story on Forbes.

 

FDA Releases St. Jude Warning Letter Reply

by • Heart Rhythms, Policy & Ethics • Tags: , , , , ,

The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks and challenges to the company’s Durata and Riata ICD leads.

Click here to read the full post on Forbes.

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Merck’s Combination Of Ezetimibe And Atorvastatin Back On NDA Path 1

by • Prevention, Epidemiology & Outcomes • Tags: , , , , , , , ,

English: Logo of the .

A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son of Vytorin.” The new drug application (NDA) submission was first rejected by the FDA in 2009 and, again, last year.

Merck said yesterday that the FDA had accepted Merck’s resubmission of its NDA, which included additional data provided by Merck in response to the FDA’s rejection of the application last year. Merck said it also planned to pursue approval of the drug in other countries.

Despite its potent cholesterol-lowering effects, the clinical benefits of ezetimibe have never been demonstrated, prompting furious debates about the proper role of surrogate endpoints. Last year the FDA rejected a new indication for Vytorin and  Zetia (ezetimibe alone) in chronic kidney disease patients, as the independent effect of ezetimibe had not been assessed in SHARP, the pivotal study for the indication. Results of the IMPROVE-IT trial, expected this year, may finally resolve the question of whether ezetimibe is beneficial.
Click here to read the Merck press release…

FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF 2

by • Heart Rhythms, Policy & Ethics • Tags: , , , , , , ,

The FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest member of the new generation of oral anticoagulants, which also includes dabigatran (Pradaxa, Boehringer Ingelheim) and rivaroxaban (Xarelto, Johnson & Johnson).

The FDA said that apixaban should not be taken by patients with prosthetic heart valves or by patients with AF caused by a heart valve problem. (Recently the FDA added a contraindication to the dabigatran label against using the drug in patients with mechanical heart valves.) The FDA said that the most serious risk associated with apixaban, as with other anticoagulants, is bleeding, including life-threatening and fatal bleeding. Patients taking apixaban will receive a patient Medication Guide. The FDA is advising health care professionals to counsel patients about the signs of symptoms of possible bleeding.

The FDA approval was based largely on the results of the highly positive ARISTOTLE trial which found that apixaban was superior to warfarin in AF patients. The FDA will likely allow BMS and Pfizer to claim that apixaban is superior to warfarin, as the press release states that “patients taking Eliquis had fewer strokes than those who took warfarin.”

Click here to download a PDF of the package insert.

Click here to read the FDA press release…

2012 In Review: A Bad Year For Conventional Wisdom 3

by • Uncategorized • Tags: , , , , , , ,

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more.

One device company, with a lot of help, did just about everything right when it introduced a radical, highly disruptive new technology. Another device company did just about everything wrong in handling a series of crises. The new generation oral anticoagulants continued to make gains– slowly– but also failed to achieve the early blockbuster success that some had thought they might achieve.

And it was another bad year for scientific integrity.

Conventional Wisdom Isn’t

Raising HDL cholesterol had to be great. Then the evidence arrived. Just last week HPS2-THRIVE put the final  nail in the niacin coffin. (I wonder what all the critics of AIM-HIGH have to say now?) And another CETP inhibitor bit the dust. The HDL hypothesis is far from dead, but any claim of benefit due to raising HDL will need to be rigorously demonstrated in a large, well-designed clinical trial.

Platelet function tests just had to be useful in guiding therapy. Then ARCTIC came along and blew a cold wind on the idea.

On a related note, many believed that testing for aspirin resistance might be a good idea. Then a paper in Circulation presented strong evidence that the entire concept of aspirin resistance might be a myth.

Triple therapy for PCI patients already receiving anticoagulation was standard clinical practice, endorsed by the guidelines. Now, after WOEST, we know that what we knew was wrong. Drop the aspirin.

Intraaortic balloon counterpulsation (IABP) has a class 1 recommendation for patients in cardiogenic shock following myocardial infarction for whom early revascularization is planned. Until IABP-SHOCK II was presented at the ESC and published in NEJM.

Depending on your perspective the FREEDOM trial either confirmed or denied conventional wisdom. We now know with near certainty that diabetics with multivessel disease have better outcomes with CABG than with PCI. An important lesson from an important trial.

Conventional wisdom had it that chelation therapy was worthless. The conventional wisdom may still be valid, but the NIH’s TACT trial means the debate will continue. It’s hard to imagine a satisfactory result to this controversy, despite the good intentions of the NIH and at least some of the TACT investigators. In general I support the concept of testing alternative therapies, especially if they gain traction in clinical practice, but it’s not clear yet whether we really learned anything from TACT (except that doing trials like this is extraordinarily hard). A trial like TACT should only be performed if it has a good chance of actually answering the big clinical question. Unfortunately, TACT didn’t do this.

TAVR: Bright Spot in a Dark Year

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Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves 1

by • Heart Rhythms, Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , , , , ,

Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that Pradaxa is now contraindicated in patients with mechanical heart valves. The change was based on a recent decision of the FDA, BI told its investigators.

The FDA action follows a similar decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which announced last week that it had recommended that Pradaxa be contraindicated in patients with prosthetic heart valves.

Both the FDA and the CHMP actions appear to be based on findings from the RE-ALIGN trial in patients with mechanical heart valves, which Boehringer Ingelheim announced last week had been stopped prematurely. (Click here for the CardioBrief story.) As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board

One cardiologist who is a dabigatran investigator told CardioBrief that the label change

is consistent with the findings in Re-Align, although I wish it were presented and published in a peer reviewed journal. I do understand the urgency on behalf of the FDA to ensure that the use does not stray beyond its labeling for A-fib given both the prospective, randomized data from Re-Align and case reports of strokes on Pradaxa with mechanical valves. I don’t think this is the final word on Pradaxa (or other new generation anticoagulants), but if we are to use them, the doses will undoubtedly be different, and presumably higher, than the doses used for A-fib. The question is whether one can find a dose that prevents thromboembolic strokes with the new generation anticoagulants at an acceptable level of bleeding. It’s also worth noting that they did not recommend Pradaxa in patients with bioprosthetic valves, but didn’t absolutely contraindicate it. Yet.

Amgen Pleads Guilty To Misbranding Anemia Drug Aranesp Reply

by • People, Places & Events, Policy & Ethics • Tags: , , , , , ,

Biotechnology giant Amgen today pleaded guilty in federal court to a misdemeanor charge of misbranding Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices.

The judge deferred a decision on the plea until Wednesday. When the final settlement is announced further details about pending civil suits against Amgen will be unveiled. The acting US Attorney said that the terms of the agreements will include multiple measures to insure that Amgen complies with regulations. The measures will mean that Amgen “won’t view this as the cost of doing business,” he said in a press conference.

The agreement includes $150 million for criminal fines and penalties and an additional $612 million civil settlement. In 2011 Amgen reported $2.3 billion in sales for Aranesp.

Aranesp is approved to treat anemia in chemotherapy patients and in anemia patients with chronic kidney disease. The label now includes a black box warning that it can increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.

Although it had been the subject of earlier questions, serious criticism emerged with the publication in 2009 of the TREAT trial, which found no clinical benefit for the drug in patients with chronic kidney disease. Results of TREAT prompted a dramatic FDA advisory committee meeting in 2010 followed by a major label revision in 2011.

Click here for a PDF of the US Attorney’s Explanation of the Charges.

Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin Reply

by • People, Places & Events, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012 the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the glass particulates and remedied the problem.”

To date, no reports of harm from the contamination have been received by the FDA. Both FDA and Ranbaxy believe there is only a low likelihood that there will be adverse events related to the problem.

The FDA said it does not anticipate a shortage of atorvastatin because of the recall, but that it “is working with other manufacturers of atorvastatin to ensure adequate market supply.”
Click to read the FDA statement…

FDA Investigation Finds No Excess Bleeding Risk For Dabigatran 1

by • Heart Rhythms, People, Places & Events, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the full FDA statement. Here is the first paragraph of the statement:

The U.S. Food and Drug Administration (FDA) has evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). Following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users.  As a result, FDA investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) for new users of Pradaxa compared to new users of warfarin.  This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The results of this Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).1 (see Data Summary). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.

DOJ Investigating Abiomed For Improper Marketing Of Impella Circulatory Support System Reply

by • Interventional Cardiology & Surgery, Policy & Ethics • Tags: , ,

Cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. The announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had been informed of the investigation on October 26. (I first heard the rumor on October 18.) No details were disclosed about the investigation.

The company also said that it believed that the FDA would begin a review to possibly reclassify its Impella devices as Class III devices, which would require FDA clearance using the more stringent premarket approval (PMA) process instead of the current, less demanding 510(k) premarket notification process. Whether because of the DOJ investigation or the FDA announcement, the stock price of Abiomed dropped 25% with the news.

This is not the first time Abiomed has run into trouble with the FDA. In June 2011 Abiomed received a warning letter from the FDA about improper marketing of Impella for unapproved indications.

As previously reported here, in December 2010 the company issued a press release announcing– and spinning– the results of the PROTECT II trial comparing Impella to the intra-aortic balloon (IAB) in high risk PCI patients. Although the trial was stopped early for futility, the press release downplayed the negative findings and instead emphasized positive trends and encouraging subgroup analyses. Last month, when the trial was finally published in Circulation, the company issued a much more restrained press release, perhaps a reflection of the company’s efforts to avoid further problems with the FDA.

Here are the relevant paragraphs from Abiomed’s press release today:
Click to continue reading…