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 evolocumab (Repatha) and alirocumab (Praluent), critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit. Expanded use of the drugs will require positive results from the large outcomes trials now underway.
Until recently it was widely believed that results from these trials wouldn't be available until 2017 at the earliest. But now Amgen has said that the results of (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk ) will finish up earlier than expected.
In its , Amgen stated that "the requisite number of events in the event driven Phase 3 cardiovascular outcomes study is expected to accrue by mid-2016, with top-line data expected in H2 2016."
Industry observers now say the results of FOURIER will likely be presented next November at the annual meeting of the American Heart Association. (Earlier this year, Amgen that the trial had completed enrollment of its about 27,500 patients.)
By contrast, the ODYSSEY Outcomes trial with alirocumab appears to be more than a year behind. , the final data collection date for the primary endpoint is December 2017, so the results could probably not be presented until the American College of Cardiology meeting in March of 2018 at the earliest. ODYSSEY Outcomes is expected to enroll 18,600 patients.
The results of FOURIER could have a very big impact on the market. Efforts to hold back usage of the drugs have been successful so far. Early fears by insurance companies of an economic Armageddon have not been realized. But a highly positive outcomes trial would almost certainly lead to increased demand for the expensive drugs. Alternatively, a negative, modestly-positive, or mixed result could lead to severely diminished expectations for the drugs.