FDA OKs Amgen’s New Anti-cholesterol Drug

The US Food and Drug Administration (FDA) has approved Amgen’s new cholesterol-lowering medication, Repatha (evolocumab) injection. Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood. The US approval of Repatha follows the marketing authorization of Repatha in Europe in July 2015.

Repatha, along with Sanofi’s/Regeneron’s Praluent (alirocumab), also a PCSK9 inhibitors, are pegged as potential blockbusters. Based on estimates for 2019 sales, a recent Thomson Reuters analysis puts potential revenues at Regeneron Pharmaceuticals and Sanofi's Praluent (alirocumab) at $4.4 billion, and Amgen's’ evolocumab at nearly $1.9 billion by 2019. Praluent received FDA approval in July, and the drug is under regulatory review in the European Union for which a decision is expected for late September.

In the US, Repatha was approved as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.

Repatha is available as a single-use 140 mg prefilled SureClick autoinjector or prefilled syringe that patients can self-administer at the recommended dose for adults of 140 mg every two weeks or 420 mg once a month. For adults with HoFH, the recommended dose is 420 mg once a month. Amgen will continue discussions with the FDA regarding the 420 mg every two weeks dosing for HoFH patients.

The US Wholesale Acquisition Cost (WAC) price of Repatha is $542.31 for one 140 mg single-use prefilled SureClick autoinjector or prefilled syringe, or $14,100 annually for the every two weeks administration. For the monthly 420 mg administration, Amgen plans to make a single injection monthly dosing option available next year. Until then, Amgen anticipates monthly administration predominately for HoFH patients. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.

“Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” said Anthony C. Hooper, executive vice president of global commercial operations at Amgen, in a company 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.”

In the US, Amgen said it will provide its RepathaReady program, comprehensive suite of services to help patients and providers, including one or more months of free Repatha through the Repatha Patient Start Program while insurance coverage is pending; the Repatha $5 co-pay card for eligible commercial patients; insurance coverage support; and injection training. Amgen also provides patient assistance for its medicines marketed in the US in a variety of ways, including free medicines through The Safety Net Foundation for qualifying individuals with no or limited drug coverage.

Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Amgen is partnered with Astellas Pharma for Repatha in Japan as part of a multi-drug collaboration the companies formed in 2013. The long-term collaboration focuses on the co-development and co-commercialization in Japan of five Amgen pipeline medicines (which includes Repatha) and also created a Tokyo-based joint venture company, Amgen Astellas BioPharma KK.

Source: Amgen

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