- The FDA has announced that Amgen's PDUFA data for the PCSK9 biologic, evolocumab, is August 27, 2015.
- Evolocumab is a PCSK9 inhibitor that has been developed to lower circulating levels of the so-called "bad" cholesterol, LDL-C. PCSK9 inhibitors are an emerging class of drugs that are in late-stage clinical trials with planned cardiovascular applications.
- Amgen is competing against Sanofi/Regeneron to get the firs PCSK9 inhibitor to market for the treatment of hypocholesterolemia. Sanofi/Regernon gained an advantage recently by paying $67.5 million for an FDA voucher to reduce review time from 10 months to 6 months. In response, Amgen filed a patent-infringement lawsuit.
Amgen has developed evolocumab as an adjunctive therapy for patients who need additional hypocholesterolemic activity in order to achieve cholesterol goals. It can also be used as monotherapy in appropriate situations.
Currently, several PCSK9 inhibitors are being tested in clinical rials, but it seems that Amgen's is closest to review. In phase III clinical trials involving 4,500 patients, evolcumab significantly lowered LDL-C and balanced dyslipidemia, with a high level of tolerability.