(Updated) –PCSK9 inhibitors have ‘the dubious distinction of being the most expensive preventive therapies by far in the history of cardiovascular medicine’ Two new economic analyses conclude that PCSK9 inhibitors are far too expensive to be cost effective. Both studies incorporate data from FOURIER, the first and still the only large cardiovascular outcomes trial with…
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Pharma Phantasy: The $30 Billion PCSK9 Inhibitor Market
August 8, 2017 by 2 Comments
–Drug company dreams up a study showing all the benefits and none of the costs or risks of PCSK9 inhibitors. Here’s a pro tip for pushing a drug (or, indeed, any aggressive treatment or screening strategy): focus exclusively on the benefits, even if they are modest at best, and completely ignore side effects and costs….
Forthcoming Expert Guideline May Upgrade PCSK9 Inhibitors
July 21, 2017 by 1 Comment
Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial might bolster the embattled cholesterol drugs.Results of the FOURIER trial…
27,000 Patient PCSK9 Inhibitor Trial Meets Main Endpoints
February 2, 2017 by 3 Comments
(Updated) –Cardiovascular outcomes finally available for PCSK9 inhibitors. Amgen announced on Thursday afternoon that the FOURIER trial had met both its primary composite endpoint (cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the even more rigorous key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). The company…
Genetic Studies Offer Hint Of Clinical Benefits-And Risks- of PCSK9 Inhibitors
November 30, 2016 by 2 Comments
–Both cardiovascular benefits and increase in diabetes seem likely. There is no more eagerly awaited question in cardiovascular medicine than the clinical role of the PCSK9 inhibitors. The first reports from a series of outcomes trials are not due until next year. But two large genetic studies published this week deliver strong indirect evidence that…
More Progress For Novel PCSK9 Drug
November 15, 2016 by Leave a Comment
–The PCSK9 synthesis inhibitor from The Medicines Company is getting close to phase 3 trials. More early information continues to accumulate about a novel cholesterol drug under development by The Medicines Company. The drug, which was initially created by Alnylam Pharmaceuticals, uses RNA interference technology to inhibit the synthesis of PCSK9 in the liver. The main…
Pfizer Ends Development Of Its PCSK9 Inhibitor
November 1, 2016 by 1 Comment
–Immune issues and diminishing efficacy doomed the new drug. Pfizer announced on Tuesday that it was discontinuing development of bococizumab, its cholesterol-lowering PCSK9 inhibitor under development. “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide…
First PCSK9 Outcome Trial Results Pushed Back To 2017
June 8, 2016 by Leave a Comment
Uptake of the new drugs likely to lag without strong outcomes data. Uptake of the new drugs likely to lag without strong outcomes data.Uptake of the new drugs likely to lag without strong outcomes data. (Updated) –Uptake of the new drugs likely to lag without strong outcomes data. There’s probably nothing more eagerly awaited in…
Court Decision In Patent Battle Threatens PCSK9 Drug
March 23, 2016 by Leave a Comment
—-One analyst thinks the decision might take Praluent off the market. A jury’s decision last week in a patent case might possibly lead to the removal of one of the new PCSK9 inhibitor cholesterol lowering drugs from the US market, according to a Wall Street analyst who has been closely following the case. Amgen, which…
Rat Study Links Neural Tube Defects To Lower PCSK9 Levels
January 3, 2016 by Leave a Comment
(Updated) PCSK9 may play an important role in neural tube development (NTD), a new study in rats suggests. The study, published in Scientific Reports, found that PCSK9 levels were significantly reduced in rat embryos with NTDs. The main focus of the paper was to identify biomarkers that could be used for the prenatal detection of NTDs, since there are now…
First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016
December 21, 2015 by Leave a Comment
In less than a year we may know a whole lot more about the PCSK9 inhibitors than we do now. Since the approval earlier this year of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Regeneron and Sanofi) critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit….
Amgen Denies Rumors About PCSK9 Inhibitors (Updated)
December 19, 2015 by 1 Comment
(Updated) Amgen says there is no truth to the rumor that the FDA is investigating post-marketing reports of serious brain infections in patients taking PCSK9 inhibitors. The Amgen statement was in response to this anonymous post on CafePharma: “The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports…
Report Concludes That PCSK9 Inhibitors Are Effective But Very Expensive
September 8, 2015 by 1 Comment
The new PCSK9 inhibitors– with an annual cost of over $14,000 a year– are far too expensive to be broadly used in eligible populations without restrictions, according to a draft report from the Institute for Clinical and Economic Review (ICER). The price of the new drugs would need to fall to nearly $2,000 in order for the drugs to…
FDA Approves Repatha, Amgen’s PCSK9 Inhibitor
August 27, 2015 by Leave a Comment
Late on Thursday Amgen announced that the FDA had approved its highly anticipated and much debated PCSK9 inhibitor, Repatha (evolocumab). The drug will be the second PCSK9 inhibitor on the market, following the approval last month of Sanofi’s and Regeneron’s Praluent (alirocumab). In a press release the FDA said Repatha “is approved for use in addition to diet…
FDA Approval Of Second PCSK9 Inhibitor Expected Soon
August 24, 2015 by 1 Comment
The FDA has until Thursday, August 27 to make its decision about Repatha (evolocumab), Amgen’s much anticipated cholesterol lowering PCSK9 inhibitor. The drug is widely expected to gain approval. Last month the FDA approved Praluent (alirocumab), Sanofi’s and Regeneron’s similar drug. Beyond approval the major questions that should be answered this week concern the drug’s label…
More Preliminary Signs That PCSK9 Inhibitors May Improve Outcomes
April 27, 2015 by Leave a Comment
More information about the highly anticipated new cholesterol lowering drugs from Amgen and Sanofi/Regeneron emerged today. A new new analysis of available data from early trials with PCSK9 inhibitors adds to the growing evidence showing that the drugs– Amgen’s evolocumab and Sanofi’s alirocumab– dramatically lower LDL cholesterol and offers additional preliminary evidence showing that they are safe and may confer a…
FDA Sprinkles Some Rain On the PCSK9 Inhibitor Parade
March 7, 2014 by Leave a Comment
In the last few years the PCSK9 inhibitors have been one of the few bright lights in an otherwise dismal field of new cardiovascular drugs. Now the FDA is raising questions that could dramatically slow down the progress of these new cholesterol-lowering drugs. Last month Regeneron disclosed that it had been “advised by the FDA that…
PCSK9 Inhibitor Enhances Cholesterol-Lowering Effect Of Atorvastatin
October 31, 2012 by Leave a Comment
When added to low-dose atorvastatin a much-discussed new monoclonal antibody to PCSK9 significantly lowers cholesterol more effectively than atorvastatin alone, according to a phase 2 study published in the New England Journal of Medicine. Earlier this year, in March, the findings of three phase 1 trials demonstrating the cholesterol-lowering effects of the drug in healthy volunteers and…
Promising Phase 1 Results For New Monoclonal Antibody to PCSK9
March 21, 2012 by Leave a Comment
Promising results from very early studies with an experimental new cholesterol-lowering drug, a monoclonal antibody to PCSK9, have been published in the New England Journal of Medicine. Evan Stein and colleagues report the results of two single-dose studies in which the drug, REGN727, was administered intravenously and subcutaneously to healthy subjects. In a third, randomized, placebo-controlled, dose-ranging…
No, CRISPR Is Not Going To ‘Cure’ Heart Disease
June 30, 2020 by Leave a Comment
No, CRISPR gene editing technology is not going to “cure” heart disease. But a New York Times story by Gina Kolata on an extremely early study in animals prominently plays up just this extremely unlikely claim. The Times story is based on a press release issued by Verve Therapeutics, a new biotechnology company founded by Sekar Kathiresan, an influential cardiologist and genomic…
The ODYSSEY Trial Ends Well— But Will It Be Enough?
March 10, 2018 by 8 Comments
Sanofi and Regeneron achieved a modest victory with the much anticipated ODYSSEY Outcomes trial of its cholesterol lowering drug Praluent (alirocumab). The trial met its primary endpoint and even reported a significant improvement in all-cause mortality. But the mortality finding has an asterisk attached to it and it is far from clear whether the overall…
Esperion Releases Top Line Results For First Pivotal Phase 3 Study
March 7, 2018 by 4 Comments
Esperion announced positive results today for the first in a series of pivotal phase 3 studies of its cholesterol lowering drug. The trial (Study 4, or 1002-048) compared bempedoic acid to placebo in 269 patients with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD who have high LDL cholesterol levels (100 mg/dl or greater)…
Moment Of Truth For Struggling And Expensive Cholesterol Drugs
February 15, 2018 by 7 Comments
It will be the moment of truth for the expensive new cholesterol drugs known as PCSK9 inhibitors. Next month we will learn much more about the PCSK9 inhibitor class of cholesterol drugs. A lot of the remaining uncertainty about the efficacy— or lack of efficacy— of these drugs will be resolved when a large cardiovascular…
CANTOS Substudy Shows Major Role For Inflammation
November 13, 2017 by 1 Comment
–Large reductions in hsCRP appeared to foretell improved outcomes. ANAHEIM — An important CANTOS trial substudy bolsters evidence that inflammation plays an independent role in cardiovascular disease (CVD) and may point toward a new targeted approach to treatment of CVD and perhaps even more profoundly impact cancer treatment. The report, presented by Paul Ridker (Brigham…
New And Improved LDL Lab Numbers
October 27, 2017 by 5 Comments
–Lab companies start reporting more accurate LDL cholesterol measurements. The LDL cholesterol number, which has been the obsessive focus of physicians and patients for several decades now, is getting a major upgrade. A new and improved method to calculate the LDL cholesterol number is starting to filter into standard laboratory reports. Until now LDL cholesterol,…
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