Repatha evolocumab regulatory update

FDA approved the Repatha Pushtronex system to deliver a once-monthly 420 mg subcutaneous dose of Amgen’s Repatha evolocumab to treat patients with high LDL-C. Amgen said the Pushtronex system -- an on-body infusor with prefilled cartridge -- will be available early next month in the U.S. The human mAb against PCSK9 is approved as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous or homozygous familial hypercholesterolemia (HeFH or HoFH) or clinical atherosclerotic cardiovascular disease (CVD) who require additional lowering of LDL-C (see BioCentury, Sept. 7, 2015).

Repatha is available in the U.S. at a 140 mg dose in prefilled pens or syringes that patients self-administer. The recommended dosage is 140 mg every 2 weeks or 420 mg once monthly in patients with atherosclerotic CVD or HeFH and 420 mg once monthly in patients with HoFH. To administer 420 mg once monthly, patients receive 3 injections of the 140 mg dose within 30 minutes. ...