UPDATE: The EMA's Committee for Medicinal Products for Human Use (CMHP) on Friday recommended marketing authorization for Repatha. That means that the product is headed for a final EU approval, likely within the next couple of months, giving Amgen a key marketing advantage over Sanofi and its rival PCSK9 drug Praluent in Europe. The big question now is: Which of the company's will win the race to a U.S. approval?
- Amgen's Repatha (evolocumab) is part of a new class of anti-cholesterol drugs, known as PCSK9 inhibitors. It is one of two PCSK9 inhibitors in development, in addition to Praluent (alirocumab), which is being co-developed by Sanofi and Regeneron
- In phase III trials, Repatha lowered LDL-C by about 60% and decreased the rate of CVD events, including heart attack, heart failure leading to hospitalization, and death, by about 50%.
- While Friday's positive rec by the EMA committee does not ensure an automatic final endorsement, , giving Repatha a first-to-market advantage in Europe. Praluent has been granted priority review status by the FDA in the U.S.
It's been a hot race between Repatha and Praluent. As PSCK9 inihbitors, these injectable drugs have the potential to change the cardiovascular (CVD) treatment landscape. Both Repatha and Praluent have generated excitement because of their ability, in clinical trials, to lower hypercholesterolemia in the hardest-to-treat patients with refractory or familial hypercholesterolemia. In the U.S., a decision on Repatha is expected in late August, while Praluent is being reviewed on July 24. While the drugs are similar, there are slight differences in terms of their massive clinical trial programs, which are still ongoing.
Want a quick primer on PSCK9 inhibitors? See the BioPharma Dive overview: 9 important things to know about PCSK9 cholesterol drugs.