US FDA advisory panel votes for approval of Amgen’s PCSK9 inhibitor Repatha

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday voted in favor of approving biotech major Amgen’s (Nasdaq: AMGN) PCSK9 inhibitor cholesterol lowering drug Repatha (evolocumab).

Hot on the heels of a positive vote for a similar product, Praluent (alirocumab) Injection from Regeneron Pharmaceuticals (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN; The Pharma Letter June 10), the Committee voted unanimously to approve Repatha for patients with homozygous familial hypercholesterolemia (HoFH), a hereditary disorder that causes high low-density lipoprotein (LDL) cholesterol and can cause heart attacks in very young people, including children.

Panellists voted 11-4 to approve Repatha in patients with high cholesterol who are at high risk of cardiovascular disease whose cholesterol cannot be lowered sufficiently using statins or other drugs. As with their review of Praluent, expert panellists stressed that long-term results are needed to judge the drug's real benefit.