Amgen receives FDA approval for PCKS9 inhibitor Repatha

THOUSAND OAKS, Calif. — Amgen announced Friday that the Food and Drug Administration had approved its new cholesterol treatment Repatha (evolocumab) injection. Repatha is intended to accompany statin therapy and diet for patients with heterozygous or homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who need to lower their LDL cholesterol.

“We are excited about today’s approval of Repatha in the U.S. as patients and physicians will now have a new treatment option to lower LDL cholesterol,” Amgen’s EVP research and development Sean Harper said. “At Amgen, we are committed to improving the lives of patients and are inspired by the potential for Repatha to aid in the global fight against one of the major risk factors for cardiovascular disease.”

Repatha is avaialable as a 140-mg prefilled single-use auto-injector. The wholesale acquisition cost of the drug in the U.S. is $542.31 for a single dose, or $14,100 annually for patients who administer Repatha every two weeks. Concerns over the cost of other PCSK9 inhibtors (the first of which was approved by the FDA in late July) led CVS Health’s Research Insitute to call for a revision of the guidelines for treatment of patients with high cholesterol. Amgen said that it is aware of these concerns, and is planning on rolling out a single monthly 420-mg dose next year.

“Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” Amgen’s EVP global commercial operations Anthony Hooper said. “We … will be working with payers and other purchasers to provide innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions and anticipated appropriate patient utilization.”

As part of these efforts, Amgen said it would launch its RepathaReady program, which will offer services for patients and providers, among them one or more months free repathat through its patient start coverage while a patient waits for insurance. It will also offer a $5 co-pay card for eligible patients, injection training and insurance coverage support.