Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year Reply

Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic’s Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their drawing boards to redesign the devices.

Click here to read the full post on Forbes.

 

No, The New Cholesterol Drugs From Sanofi And Amgen Aren’t Going To Cost $150 Billion A Year Reply

In an article on the Health Affairs blog 4 CVS executives speculate that the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi might achieve yearly sales of $150 billion or even higher. I think these numbers are a bit silly. But first let’s take a look at their extremely bullish case….

Click here to read the full post on Forbes.

 

Amgen Door Hanger

Califf To Leave Duke To Become FDA Deputy Commissioner Reply

The FDA announced today that Duke University cardiologist Robert Califf will be the next FDA Deputy Commissioner for Medical Products and Tobacco. The agency said that Califf will be responsible for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.”

Click here to read the full post on Forbes.

 

Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race Reply

Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen.

Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics License Application (BLA) for alirocumab, their PCSK9 inhibitor…

Click here to read the full post on Forbes.

 

FDA Approves New Oral Anticoagulant From Daiichi Sankyo 1

And then there were four.

Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace…

Click here to read the full post on Forbes, including a comment from Sanjay Kaul.

 

FDA Advisory Panel Gives Tepid Support To New Daiichi Sankyo Drug Reply

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban(Savaysa), but the outcome will likely result in a drug that will be on the market but that few physicians will prescribe until further studies are performed.

Click here to read the full post on Forbes.

First Drug-Coated Balloon Approved By FDA For Leg Blockages Reply

The FDA today announced that it had approved for use in the US the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the thigh and knee (superficial femoral and popliteal arteries). The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012.

Click here to read the full post on Forbes.

 

FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device Reply

The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use.

Click here to read the full post on Forbes.

 

Novel Boston Scientific Device Headed For Another Rough FDA Panel Reply

On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel.  The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than a decade and its approval has twice been postponed by the FDA.  Briefing documents released ahead of Wednesday’s panel suggest that the third time may not be the charm for Watchman, though close FDA watchers believe the device may ultimately squeak through.

Click here to read the full post on Forbes.

 

Cholesterol Drugs Haunted By Ghosts Of Past, Present, And Future Reply

Cholesterol drugs, both new and old, are in the news again. There’s a lot going on now but the picture won’t really become clear until next month, when the results of a decade-old trial will finally be revealed. Briefly, here’s what’s happening:

  • Two new trials presented fresh evidence that PCSK9s, the much discussed new class of cholesterol drugs, have powerful LDL-lowering properties.
  • A new drug from Esperion, the phoenix of biotech companies, also showed promising results. The drug, ETC-1002, is a few years behind the PCSK9s in development but has some important theoretical advantages that may prove very important down the road.
  • At the annual meeting of the American Heart Association in November the results of the IMPROVE-IT trial will be presented. The results of this trial, as I have argued in the past, may have a broad if not decisive impact on the future of the PCSK9s and ETC-1002.

 …

Click here to read the full post on Forbes.

 

FDA Approves New Weight Loss Drug From Orexigen And Takeda Reply

The FDA announced today that it had approved Contrave, the long-awaited and much-disputed weight loss drug.  The drug is a combination of two drugs already approved for other indications: naltrexone hydrochloride, which is used to combat alcohol and opioid dependence, and bupropion, which is used to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment. Contrave is manufactured by Orexigen and will be distributed by Takeda.

Click here to read the full post on Forbes.

 

FDA Advisory Panel Offers Cautious Support For Polypill Reply

The controversial polypill took one step closer to reaching the US market after receiving a mostly positive reception from the FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday. The idea for the polypill– which in this case would be composed of aspirin, a statin, and one or more blood pressure drugs– has been kicking around for more than a decade and has attracted considerable doses of support as well as skepticism.

An all-star group of cardiology leaders– including Sir Nicholas Wald, Salim Yusuf, Suzanne Oparil, Sidney Smith, and Clyde Yancy– helped provide the spoonful of sugar that helped the committee swallow the polypill. The FDA also eased the way by limiting the discussion to the use of the polypill for secondary prevention in people who have already had a MI or a stroke.

Click here to read the full post on Forbes.

 

FDA Once Again Reaches Conclusions At Odds With Its Own Staff Reply

Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists.  Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the  FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug.

Back in 2010 the FDA said that it was initiating a safety review of olmesartan due to troubling findings from 2 clinical trials that raised the possibility that patients with type 2 diabetes taking olmesartan might have an increased risk of cardiovascular death. Four years later the FDA announced  that it had completed that review.

Click here to read the full post on Forbes, including comments from Sanjay Kaul and Franz Messerli and Sripal Bangalore.

FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant Reply

A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect.

REGULATE-PCI is a phase 3 trial comparing Revolixys to bivalirudin (Angiomax, The Medicines Company) in 13,000 patients undergoing PCI.

Click here to read the full post on Forbes.

 

 

 

FDA Ends Olmesartan Safety Review, But… Reply

The FDA announced on Tuesday that it had completed its safety review of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when results from the ROADMAP trial showed that patients with type 2 diabetes taking olmesartan had an increased risk of cardiovascular death.

Now the FDA says that it “has found no clear evidence of increased cardiovascular risks associated” with olmesartan in diabetic patients.

Click here to read the full post on Forbes.

 

 

FDA Recalls Another Batch Of Generic Metoprolol Reply

The FDA has recalled more than 13,000 bottles of metoprolol succinate extended release tablets manufactured by Dr. Reddy’s Laboratories. Two months ago the agency recalled another lot of generic metoprolol from a different company, Wockhardt. Both recalls were for medicines manufactured at facilities in India. There have been multiple reports in recent years of problems with generic drugs made in India.

Click here to read the full post on Forbes.

 

Yet Another Delay For Boston Scientific’s Watchman Device Reply

Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said that it had been informed by the FDA that it will need to undergo yet another advisory panel before gaining approval.

Click here to read the full post on Forbes.

Watchman_2

 

FDA Approves Novel Implanted Sensor To Monitor Heart Failure Reply

The FDA announced today that it had approved the CardioMEMS Champion HF System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of  NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted in the pulmonary artery, a catheter-based delivery system, and a system that acquires and processes PA pressure measurements from the implanted monitor and transfers the data to a secure database.

Click here to read the entire post on Forbes.

 

FDA Rejects Novel Novartis Drug For Acute Heart Failure Reply

Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy.

Click here to read the full post on Forbes.

 

 

FDA Approves Novel Merck Drug To Prevent Heart Attacks And Strokes Reply

The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (heart attack), stroke, cardiovascular death, and revascularization procedures. The drug is approved for use in people with a history of MI or peripheral arterial disease. The approval represents an amazing turnaround for a drug that had experienced nearly as many ups and downs as an amusement park roller coaster.

Click here to read the full post on Forbes.

 

FDA Comes Out Against Aspirin To Prevent First Heart Attacks 1

In the latest development in a long-simmering debate, the FDA has announced that aspirin should not be marketed for the prevention of a first heart attack or stroke in people with no history of cardiovascular disease. The announcement follows FDA’s rejection on Friday of Bayer Healthcare’s decade-old  petition requesting approval of a primary prevention indication. [PDF of FDA rejection letter]

Click here to read the full post on Forbes.