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…
Ebbinghaus Study May Help Refute Doctor Google
March 18, 2017 by 3 Comments
–No neurocognitive adverse effects linked to very low LDL levels Reaching very low LDL levels with a PCSK9 inhibitor was not associated with any increase in neurocognitive adverse events, according to the largest and most rigorous study to assess the topic to date. Small and preliminary studies have raised concerns over the possibility of the…
FOURIER Shows New Cholesterol Drugs Work, But Are They Worth It?
March 17, 2017 by 6 Comments
–Doctors and patients now must wrestle with a modestly effective but expensive drug. As it turns out the PCSK9 inhibitor saga ends not with a bang but a whimper. The results of the highly anticipated FOURIER trial show that the drugs work, though not as powerfully as many had hoped and expected. The question now…
Repatha Approved for Single Monthly Injection
July 11, 2016 by Leave a Comment
–New hands-free system replaces three sequential shots The FDA has approved a device that can deliver a single monthly injection of evolocumab (Repatha), the cholesterol-lowering PCSK9 inhibitor manufactured by Amgen. Repatha is currently administered by subcutaneous injection in a 140-mg dose every 2 weeks or as a 420 mg monthly dose. Until now, the monthly…
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…
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…
Amgen’s Repatha Beats Out Competitor For Spot On CVS/Caremark Formulary
November 23, 2015 by Leave a Comment
CVS Health announced today that Amgen’s Repatha will be the only PCSK9 inhibitor on the CVS/Caremark formulary. This gives Amgen its first big win among the pharmacy benefits managers against Sanofi’s Praluent in the battle over the market for the powerful but expensive new cholesterol-lowering drugs. Previously Express Scripts had announced that both drugs would be placed…
Amgen Requires Patients in Repatha Copay Program To Surrender Their Privacy
October 22, 2015 by 3 Comments
(This story was updated on October 23 with a statement from Amgen. It was again updated on October 27 with new information about Amgen’s patient privacy policy for a second drug, Enbrel.) (For an important followup to this story please see: Amgen Takes The Pledge To Respect Patient Privacy) The tumult over the new cholesterol…
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…
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