A regulatory advisory panel on Wednesday recommended approval for Repatha, a new cholesterol drug from Amgen Inc., although use should be limited to patients with high risk of heart disease.
The Thousand Oaks biotech presented data Wednesday in a meeting with the Food and Drug Administration committee from clinical trials with 6,800 patients. The panel voted 11-4 to approve Repatha for patients with high cholesterol whose cholesterol cannot be controlled with other treatments. Also, the panel voted unanimously for Repatha as a treatment for a rare genetic disorder that causes high cholesterol in young patients.
While the FDA isn’t required to follow panel recommendations, it normally does so. Final FDA approval or rejection of Repatha is expected by Aug. 27, the agency’s target date for a decision. An advisory panel at the European Union’s regulatory agency gave Repatha a positive recommendation last month.
Repatha, also called evolocumab, is a new type of cholesterol treatment that blocks a chemical called PCSK9, which hinders the liver's ability to remove cholesterol in the bloodstream. Cholesterol build-up inside arteries leads to heart disease, the leading cause of death in the United States.
The FDA panel approved another PCSK9 blocker on Tuesday from Sanofi, a French pharmaceutical company.
Amgen shares closed up 75 cents or a fraction of a percent to $155.55 on the Nasdaq.
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