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Amgen

Amgen Seeks Approval for Monthly Dosage of Repatha

September 17, 2015

Amgen is seeking approval for its 420 mg monthly dosage form of Repatha just over two weeks after the FDA signed off on the PCSK9 inhibitor to control low-density lipoprotein cholesterol.

Amgen recommends the 420 mg once-monthly dosage for patients with homozygous familiar hypercholesterolemia, or HoFH.

The FDA approved a two-week 140 mg version of Repatha (evolucumab) on Aug. 27 for use in addition to diet and maximally tolerated statin therapy in adults with HoFH and two other lipid disorders — heterozygous familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes. PCSK9 inhibitors work by blocking a particular protein, which increases the number of receptors on the liver available to rid the blood of LDL-C.

The FDA approval followed July’s EU approval, making Repatha the first PCSK9 inhibitor approved for sale anywhere in the world. A second PCSK9, Sanofi and Regeneron’s Praluent (alirocumab), won the U.S. race for approval, getting the FDA’s green light on July 24.

At the time of approval, Amgen said the wholesale acquisition cost would be $542 for one 140 mg single-use prefilled syringe or injector, or $14,100 annually — below Praluent’s $14,600 WAC. As the WAC doesn’t reflect discounts or rebates, Amgen expects actual costs to be lower.

Amgen did not release cost projections for the monthly dose. — John Bechtel