FDA Approves Repatha, Amgen’s PCSK9 Inhibitor

Late on Thursday Amgen announced that the FDA had approved its highly anticipated and much debated PCSK9 inhibitor, Repatha (evolocumab). The drug will be the second PCSK9 inhibitor on the market, following the approval last month of Sanofi’s and Regeneron’s  Praluent (alirocumab).

In a press release the FDA said Repatha “is approved for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.” The indication appears to be broadly similar to the Praluent indication, though the Praluent indication did not specifically include the very small group of patients with homozygous familial hypercholesterolemia.

“Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” said the FDA’s John Jenkins.

The FDA said that in clinical trials Repatha led to an average reduction in LDL cholesterol of 60% compared to placebo. Common side effects include “nasopharyngitis, upper respiratory tract infection, flu, back pain, and injection site reactions.” Some patients taking Repatha may have allergic reactions. The FDA said these patients should stop taking the drug and seek medical help in the case of a serious reaction.

In a press release Amgen said that a single-use 140 mg prefilled injection would cost $542.31, or $14,100 annually for the every two weeks administration. The yearly price is $500 less than the price set by Sanofi and Regeneron for Praluent. Amgen also plans to offer a monthly 420 mg injection, mostly for patients with homozygous FH.

The wholesale acquisition cost (WAC) for both drugs does not reflect the actual cost to most payers or patients. Amgen said that the “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 also said that it “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.”

Repatha

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