FDA approves second PCSK9 inhibitor

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The FDA approved evolocumab (Repatha) on Aug. 27, the second in a new class of cholesterol-lowering medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

The injectable drug was  approved for adults with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein (LDL) cholesterol. Patients also are recommended to take the maximally tolerated statin therapy and improve their diet.

Amgen, the drug’s manufacturer, said the wholesale acquisition cost (WAC) of evolocumab is $14,100 per year. Patients will take one 140 mg single-use prefilled autoinjection or prefilled syringe every two weeks. The company said a monthly 420 mg injection option would be available next year. The monthly dose is recommended for patients with HoFH.

Amgen noted in a  news release that the cost to patients, payers and health systems is projected to be lower than the WAC because it did not include any negotiated discounts or rebates.

“Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” Anthony C. Hooper, Amgen’s executive vice president of Global Commercial Operations, said in statement. “We are confident in the ability of Repatha to demonstrate real-world effectiveness and value based on intensive LDL cholesterol reductions, and 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. By partnering with payers to implement these programs, we can help ensure that all appropriate patients who could benefit from Repatha will have access to this important new therapy."

The cost of evolocumab is slightly lower than that of alirocumab (Praluent, Regeneron Pharmaceuticals and Sanofi Aventis), a PCSK9 inhibitor that the FDA  approved on July 24. The annual WAC of alirocumab is $14,600 for daily 75 mg or 150 mg doses. The FDA approved alirocumab as an adjunct to diet and statins to treat patients with HeFH or clinical atherosclerotic cardiovascular disease who have not been able to lower their LDL cholesterol.

The approval of evolocumab was based on the results of one 52-week and eight 12-week placebo-controlled trials that included patients with primary hyperlipidemia. Patients who received evolocumab had an average reduction in LDL cholesterol of approximately 60 percent compared with the placebo group.

The following adverse events occurred in at least five percent of patients treated with evolocumab and in more patients than in the placebo group: nasopharyngitis, upper respiratory tract infection, influenza, back pain and injection site reactions.

Amgen is currently conducting trials to determine evolocumab’s effect on cardiovascular morbidity and mortality and adding evolocumab to statins for reducing cardiovascular risk.