UPDATED: FDA gives Amgen approval for its once-monthly cholesterol device


Amgen said the FDA has approved its Repatha (evolocumab) Pushtronex system, the first hands-free, once-monthly delivery option for a PCSK9  inhibitor.

Evolocumab is indicated as an adjunct to diet and maximally tolerated statin therapy to lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.

The company said it expects to have the device on the market in August. The device will carry a wholesale price of $14,100 annually, the same as the twice-weekly product, the Thousand Oaks, CA-based company said in its announcement.

When initially approved last summer by the FDA, Repatha dosing was 140 mg every two weeks or 420 mg once a month but the monthly dose required three injections given within 30 minutes. 

“Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration," the company said in its announcement.

The approval gives Amgen a leg up on its competition in what is a very heated battle within the PCSK9 market between it and Sanofi ($SNY) and Regeneron ($REGN) to provide patients a new drug that blocks a protein that inhibits the body's natural system to eliminate "bad" cholesterol.

Analysts at first thought sales would soar because the new drugs would be used in conjunction with inexpensive generic statins taken by millions of people who for lowering cholesterol, or at least for those who can’t tolerate statins.

The FDA, however, stopped short of designating them for that indication. Instead, approving them only for patients with a hereditary form of high cholesterol, and those at high risk of heart problems who haven't responded to aggressive statin therapy.

Insurers responded by limiting the use of the drugs that had an annual cost far above that of cheap generic statins, requiring them and their patients to go through a document-intensive preapproval process.

The result was slow sales. Analysts had forecast both drugs would generate about $3 billion in annual sales by 2022. Repatha was forecast to have about $185 million in sales this year and Praluent as much as $265 million, yet in the first quarter both tallied only about $20 million.

- here’s the release

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