- Sanofi and Regeneron have developed a PCSK9 inhibitor, alirocumab, to lower cholesterol. This is one of two competing products in this class -- the other being Amgen's evolocumab -- in the final stages of development.
- There are currently four ongoing phase III clinical trials evaluating alirocumab.
- In August, Sanofi/Regneron purchased a $67.5 million voucher from BioMarin that can be used for priority review of alirocumab. The companies have yet to file the drug for approval.
Amgen already filed its PCSK9 inhibitor, evolocumab, with the FDA last week, putting the company in a tight race with Sanofi and Regeneron to see whose product is approved first. According to data recently presented at the European Cardiology Society meeting in Barcelona, alirocumab has met all of its endpoints in phase III trials.
In a 52-week, placebo-controlled trial evaluating alirocumab, there was a 57% reduction in low-density lipoprotein cholesterol (LDL-C) levels in alirocumab-treated patients, compared with a 4% increase in placebo-treated patients. In a separate study, 1.4% of alirocumab-treated patients, compared with 3% of placebo-treated patients, suffered a major cardiovascular event. The introduction of PCSK9 inhibitors will expand treatment options for patients with hypercholesterolemia and potentially shift the treatment paradigm entirely.