First PCSK9 Outcome Trial Results Pushed Back To 2017


–Uptake of the new drugs likely to lag without strong outcomes data.

There’s probably nothing more eagerly awaited in cardiovascular medicine than results from the large cardiovascular outcomes trials (CVOTs) with the new cholesterol-lowering PCSK9 inhibitor drugs.

It now appears that everyone will have to wait a little longer for those results.

Sean Harper, the executive vice president for research and development at Amgen, yesterday said that the top line results of Fourier (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk ) will likely be available in the first quarter of 2017.

Amgen had previously said that they thought the top line results would be available in the second half of this year.

Amgen said it is now “working towards a timeline of submitting these results for presentation at ACC and publication in a medical journal.” The American College of Cardiology scientific sessions will take place in March in Washington, DC. Harper said that the trial has now accrued more than 85% of requisite events and that it expects accrual of the remaining number of events over the course of the summer.

Repatha (evolocumab), the Amgen drug, and Praluent (alirocumab), a similar drug from Regeneron and Sanofi, were approved last summer but have struggled in the market. A major barrier to uptake of these highly promising but expensive drugs has been the absence of evidence demonstrating that the drugs significantly lower cardiovascular risk. The drugs have also encountered stiff resistance from insurance companies.

First results from the Regeneron CVOT, the Odyssey Outcomes trial are not expected until December 2017, with full results likely not available until the American College of Cardiology meeting in March of 2018 at the earliest.

Hat tip: @AndyBiotech

Update: 27,000 Patient PCSK9 Inhibitor Trial Meets Main Endpoints


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