Amgen files for FDA approval of monthly dosing option for PCSK9 inhibitor Repatha

Amgen on Friday announced the submission of a marketing application to the FDA for a once-monthly dosing option for the PCSK9 inhibitor Repatha (evolocumab). The therapy is currently approved to be administered either biweekly, as a single-use SureClick autoinjector or prefilled syringes, or once per month, using three SureClick autoinjectors or prefilled syringes.

Repatha was cleared by the FDA last month for lowering LDL cholesterol levels as an adjunct to diet and maximally-tolerated statin therapy in adults with heterozygous familial hypercholesterolaemia, homozygous familial hypercholesterolaemia (HoFH) or clinical atherosclerotic cardiovascular disease. The recommended dose for adults is 140 mg every two weeks or 420 mg once a month. Amgen noted that for patients with HoFH, the recommended dose is 420 mg once a month, with the new submission allowing this to be administered as a single injection.

Sean E. Harper, executive vice president of R&D at Amgen, remarked that "patients who are in need of lowering their cholesterol levels are often on more than one medication and some may prefer a single-dose option for receiving Repatha once monthly." The therapy, which was approved by regulators in Europe in July, costs $14 100 a year for bi-weekly administration.

Earlier this week, an analysis released by the Institute for Clinical and Economic Review suggested that the prices of PCSK9 inhibitors, which also include Sanofi and Regeneron Pharmaceuticals' Praluent (alirocumab), are excessive. Praluent, which is given every other week by injection in doses of 75 mg or 150 mg, has a US price of $14 600 for annual treatment. Meanwhile, the CVS Health Research Institute has called for a review of current guidelines for the management of high cholesterol in light of the availability of PCSK9 inhibitors.

For related analysis, see Spotlight On: Will payers be able to extract HCV-like discounts on anti-PCSK9 mAbs?

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