(Reuters) - Amgen Inc’s cholesterol fighting drug was approved by the European Commission, giving the keenly anticipated treatment a head start over a rival drug being developed by Regeneron Pharmaceuticals Inc and Sanofi SA.
This is the first approval by any regulator for PCSK9 inhibitors, a new class of biologic drugs that are injected. They are expected to cost much more than statins such as Pfizer Inc’s Lipitor.
The European approval for Repatha will cover patients with a genetic predisposition to high cholesterol and those intolerant of statins or cannot realize enough benefit from them, the biotechnology company said on Tuesday.
Amgen did not immediately reveal when the drug would be available or its pricing strategy.
Repatha and its rival drug Praluent are expected to generate global annual sales of more than $2 billion each by 2020, according to Thomson Reuters Cortellis.
Amgen’s drug is designed for biweekly doses of 140 mg or a monthly dose of 420 mg on top of statins if patients can tolerate them.
The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined, Amgen said.
A panel to the U.S. Food and Drug Administration recommended the approval of both drugs last month. The regulator is expected to make its decision this summer.
Amgen’s stock was up about 1 percent at $165.58 on the Nasdaq in premarket trading.
Reporting by Natalie Grover in Bengaluru; Editing by Joyjeet Das