FDA Approves Repatha for High Cholesterol

A leading cause of heart disease

By Scott Roberts

Friday, August 28, 2015

FRIDAY, Aug. 28, 2015 (HealthDay News) -- Repatha (evolocumab) has been approved by the U.S. Food and Drug Administration, the second non-statin drug in its class approved to treat high cholesterol.

The injected drug, among a new class called PCSK9 inhibitors, is sanctioned for people who are unable to reduce levels of the so-called LDL "bad" cholesterol with statin therapy and exercise, the agency said in a news release.

Low-density lipoprotein, commonly known as LDL, builds up in the blood from natural and food sources, and is a leading cause of heart disease. About one in four deaths in the United States is linked to heart disease, making it the top cause of death among men and women. The condition kills about 610,000 people in the United States annually, the FDA said.

Repatha is an antibody that targets the PCSK9 protein, which inhibits the liver's ability to remove LDL from the blood. Its most common side effects include nasal and throat inflammation, upper respiratory infection, flu, back pain and injection-site reactions.

In a clinical study, participants taking Repatha saw an average drop in LDL cholesterol of about 60 percent, compared with those who took a placebo, the FDA said.

Last month, the agency approved Praluent (alirocumab), the first-approved drug in the same class of medications as Repatha.

Repatha is marketed by Amgen, based in Thousand Oaks, Calif.

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