FDA approves second nonstatin drug to treat patients with high cholesterol
Repatha is approved for those who can't lower cholesterol with statins and exercise.
HealthDay News — The FDA has approved Repatha (evolocumab), the second nonstatin drug in its class, for treating certain patients with high cholesterol.
The injected drug, among a new class called PCSK9 inhibitors, is approved for patients who are unable to reduce levels of low-density lipoprotein (LDL) cholesterol with statin therapy and exercise, according to the FDA. 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 had an average decrease in LDL cholesterol of about 60%, compared with those who took a placebo. The drug's 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," said John Jenkins, MD, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research.
Repatha is marketed by Amgen, based in Thousand Oaks, Calif.
For more information, see the full press release from the FDA here.