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…
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…
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…
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…
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…
Cholesterol Wars: The Reimbursement Battle Begins
August 28, 2015 by 1 Comment
(Updated) The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape…
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…
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