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Biotech Stocks Facing FDA Decision In July

Amgen Inc
Amgen Inc

Amgen Inc. (AMGN) awaits FDA word on its supplemental Biologics License Application for a monthly administration single-dosing option for cholesterol-lowering medication Repatha on July 10, 2016.

The current approved option is subcutaneous administration of Repatha 140 mg every 2 weeks or 420 mg once monthly in abdomen, thigh, or upper arm. In order to administer 420 mg, 3 Repatha injections are given consecutively within 30 minutes.

Repatha was approved by the FDA last August as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (FH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Repatha is also indicated as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous FH who require additional lowering of LDL-C.

Amgen reported sales of Repatha for the first time in the first quarter of 2016 – recording just $16 million compared to analysts’ expectations of $27 million.