(Bloomberg) — Amgen Inc. (NYSE:AMG) won U.S. approval for its powerful cholesterol-lowering drug Repatha for certain patients, making it the second in a new class of treatments to come to market.
The Food and Drug Administration (NYSE:FDA) limited sales of Repatha to people with hard-to-treat levels of bad cholesterol, according to a statement from the agency. The injection will cost $14,100 a year, Amgen said, and will be available in the U.S. next week.
Repatha belongs to a category of drugs known as PCSK9 inhibitors designed to help patients with ultra-high bad, or LDL, cholesterol who can’t get their condition under control with widely used statins such as Pfizer Inc.’s Lipitor. Sanofi and Regeneron Pharmaceuticals Inc. won approval on July 24 for their PCSK9 drug, Praluent.
Repatha was approved in the European Union on July 21 for patients with uncontrolled cholesterol who require additional intensive reduction of LDL cholesterol.
Express Scripts Holding Co. (Nasdaq:ESRX), the U.S.’s largest manager of prescription drug benefits, said PCSK9s could be the most expensive therapies ever seen, costing as much as $100 billion a year “if not managed properly.” As many as 10 million Americans may have conditions that would make them eligible for the drugs.
The pharmacy manager said Thursday that it would make a decision on how to cover the new drugs in the next several weeks. It didn’t rule out excluding either Amgen’s or Sanofi and Regeneron’s treatment to force price concessions. In the meantime, it will cover both.
“Our preference would be that both Amgen and Sanofi/Regeneron provide our clients favorable pricing so that it would make sense for our national formulary to cover both products,” David Whitrap, an Express Scripts spokesman, said in an e-mail.