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…
New Economic Analyses Fail To Make Case For PCSK9 Inhibitors
August 23, 2017 by 1 Comment
(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…
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…
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…
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…
New Cholesterol Drugs: Highly Effective But Important Questions Remain
March 15, 2015 by Leave a Comment
New information emerged today about two new cholesterol-lowering drugs that have been attracting a lot of attention. Data about the PCSK9 inhibitors– evolocumab, under development by Amgen, and alirocumab, under development by Sanofi and Regeneron– were published in the New England Journal of Medicine. The effects of the two drugs appeared to be broadly consistent. Both lowered LDL cholesterol powerfully,…
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