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. 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 Fourier (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk ) will finish up earlier than expected. In its third quarter report 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 announced that the trial had completed enrollment of 27,5000 patients.)
By contrast, the Odyssey Outcomes trial with Praluent appears to be more than a year behind. According to ClinicalTrials.Gov 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 of 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.
Marilyn Mann, a patient advocate, offered the following comment: “This is good news that outcomes data on Repatha will be available sooner than expected. Patients who are in need of additional therapies to control their cardiovascular risk will welcome greater certainty about Repatha’s benefits and risks.”