FDA Approval Of Second PCSK9 Inhibitor Expected Soon
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...
View ArticleFDA Approves Repatha, Amgen’s PCSK9 Inhibitor
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,...
View ArticleAmgen Requires Patients in Repatha Copay Program To Surrender Their Privacy
(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.) The tumult...
View ArticleAmgen’s Repatha Beats Out Competitor For Spot On CVS/Caremark Formulary
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...
View ArticleAmgen Denies Rumors About PCSK9 Inhibitors (Updated)
(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...
View ArticleFirst Outcomes Trial Results For PCSK9 Drugs Will Come In 2016
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...
View ArticleCourt Decision In Patent Battle Threatens PCSK9 Drug
—-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...
View ArticleFirst PCSK9 Outcome Trial Results Pushed Back To 2017
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...
View ArticleRepatha Approved for Single Monthly Injection
–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...
View ArticleFOURIER Shows New Cholesterol Drugs Work, But Are They Worth It?
–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...
View ArticleEbbinghaus Study May Help Refute Doctor Google
–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...
View ArticleForthcoming Expert Guideline May Upgrade PCSK9 Inhibitors
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...
View ArticlePharma Phantasy: The $30 Billion PCSK9 Inhibitor Market
–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...
View ArticleMoment Of Truth For Struggling And Expensive Cholesterol Drugs
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...
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