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Amgen seeks FDA approval for monthly dosing option for Repatha

Sept 11 (Reuters) - Amgen Inc said it had asked the U.S. Food and Drug Administration to approve a monthly single-dosing option for its recently approved cholesterol drug, Repatha.

The FDA approved Repatha, one of two approved treatments in a new class of injectable "bad" cholesterol-lowering drugs called PCSK9 inhibitors, on Aug. 27.

The drug is approved for patients with hereditary forms of high cholesterol - heterozygous familial hypercholesterolemia (HeFH) and a rarer homozygous (HoFH) form of the condition, in addition to those with cardiovascular disease.

It is given as a 140 mg injection every other week or as a monthly injection of 420 mg, which is recommended for HoFH patients, the company said.

At the time of approval, Amgen had said it planned to make the monthly dosing option available next year.

Repatha competes with a similar drug from Regeneron Pharmaceuticals Inc and Sanofi SA, Praluent, which is given every other week by injection in doses of 75 mg or 150 mg.

(Reporting by Natalie Grover in Bengaluru; Editing by Ted Kerr)


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