An FDA committee unanimously agreed to expand the indication for Vascepa to include cardiovascular prevention; the number of enrollments through the HealthCare.gov marketplace has decreased 20% from last year; Dollar Tree has received a warning for selling medications imported from foreign manufacturers with safety violations.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 late yesterday to approve the prescription-strength, fish oil—derived drug Vascepa (icosapent ethly) for use in patients at high risk for heart attacks and strokes, according to The Washington Post, even if they currently take statins. Forty million people in the US currently take statins to lower their low-density lipoprotein cholesterol levels, but due to excessive triglyceride levels, their risk of cardiovascular problems remains elevated. Vascepa was originally approved in 2012 for use in patients with extremely high triglyceride levels (500 mg/dL). This second indication could mean revenue in the billions for Amarin Corp. A final decision is expected next month.
In the first 2 weeks of open enrollment, about 932,000 Americans have signed up for a health plan on the HealthCare.gov marketplace. Compared with the same time last year, the decrease means close to 244,000 fewer people signed up in the initial 2 weeks this year, according to Modern Healthcare. Technical difficulties may have prevented 100,000 alone from signing up on the first day. For those who did, however, most were renewing coverage, and those choosing a new plan rose. Last year, 11.4 million gained coverage. The open enrollment period runs from November 1 through December 15.In a November 6 letter, the FDA chastised Dollar Tree for continuing to sell over-the-counter medications from foreign companies with health and safety violations, despite a promise not to do so, according to STAT. Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said, “The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable.” The warning comes on the heels of the FDA’s discovery last year that some lots of blood-pressure medicine valsartan were contaminated with NDMA, a possible carcinogen once used in rocket fuel, and ongoing fears of foreign-manufactured drugs entering the US market.