First PCSK9 Blocker Wins FDA’s Okay

Sanofi and Regeneron have received FDA’s green light for Praluent, the first drug in the U.S. that blocks the cholesterol regulator proprotein convertase subtilisin/kexin type 9 (PCSK9). Praluent dramatically lowers levels of low-density lipoprotein, or “bad,” cholesterol and is approved to treat people whose cholesterol is not sufficiently lowered with statins. Priced at $14,600 per year, the drug is expected to bring in billions of dollars in sales. Sanofi beat out Amgen, which is expected to gain approval for its PCSK9 inhibitor next month, by paying $67.5 million for a voucher that gave Praluent an accelerated FDA review.