The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously concluded that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular (CV) events in adults with elevated triglyceride levels (?135 mg/dL) and other risk factors for CV disease. The FDA’s final decision on the label expansion is expected by the PDUFA date of Dec. 28.
Regenxbio Inc., of Rockville, Md., filed suit against the FDA, challenging the agency’s clinical hold on the company’s RGX-314, a gene therapy being developed to treat wet age-related macular degeneration (AMD) and diabetic retinopathy. In its complaint for declaratory and injunctive relief, Regenxbio said the FDA issued the clinical hold Oct. 18 without notice or explanation, violating the agency’s own regulations as well as the law. Since then, the FDA has rebuffed the company’s repeated attempts to get an explanation, according to the complaint.