FDA Approves Repatha for Certain Patients With High Cholesterol
Approved for patients unable to get LDL cholesterol under control with current treatment options
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 low-density lipoprotein (LDL) cholesterol with statin therapy and exercise, the agency said in a news release. Last month, the agency approved Praluent (alirocumab), the first-approved drug in the same class of medications as Repatha.
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. Its most common side effects include nasopharyngitis, upper respiratory infection, flu, back pain, and injection-site reactions.
"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," John Jenkins, M.D., director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, said in a statement.
Repatha is marketed by Amgen, based in Thousand Oaks, Calif.