Good Repatha data for Amgen ahead of FOURIER
- In topline results announced by Amgen yesterday, Repatha (evolocumab) reduced the need for apheresis in patients with high LDL-cholesterol levels who had been given regular apheresis and statin therapies.
- While apheresis is an effective way to reduce LDL-cholesterol in high-risk patients with uncontrolled lipid levels, it's a costly, invasive and time-consuming weekly or bi-weekly process.
- The results come ahead of the Repatha FOURIER outcomes data expected to be presented this month at the American College of Cardiology (ACC) 66th Annual Scientific Session next week.
According to Sean Harper, head of R&D at Amgen, the positive data from trials of its PCSK9 inhibitor Repatha "suggest patients may have an alternative option to help them manage their cholesterol."
While once expected to be instant blockbusters, the PCSK9 inhibitors have faced slow uptake. The relatively poor performance of the products to date is largely due to high prices and lack of outcomes data.
But that could soon change. Last month, Amgen got a stock boost when it announced positive topline results from its FOURIER cardiovascular outcomes study, showing treatment with Repatha met its primary endpoint by reducing the risk of cardiovascular death, heart attack, stroke and hospitalization. Amgen has been waiting four years for the 27,500-patient study to read out and prove Repatha is cardio-protective.
The full results of FOURIER are expected to be reported at the end of this week at ACC. If strong, they could provide long awaited evidence for physicians and payers of whether PCSK9 drugs improve outcomes.
J.P. Morgan analysts expects a relative risk reduction of 17% to 20%, whereas Mizuho analysts consider 20% the minimum the study needs to meet to be considered meaningful. Some investors and analysts are hoping for a risk reduction of as much as 35%.
Good results also could drive up sales, not only for Repatha but also for Sanofi and Regeneron's competing product Praluent (alirocumab).
A ongoing patent battle could potentially blunt Praluent's potential, although recent legal setbacks haven't seemed to carry through to sales yet.
Follow Suzanne Elvidge on Twitter