Lorcaserin Safety Questions Can Be Answered In Post-Market Study, Panel Tells FDA
This article was originally published in The Pink Sheet Daily
FDA’s Endocrinologic and Metabolic Advisory Committee backs approval of Arena’s weight-loss drug 18 to 4 with one abstention. Uncertainty over the risk for heart disease remains a prime concern for panel members.
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Vivus will benefit from downsizing at other firms, Chief Commercial Officer Mike Miller says. The company will aggressively seek formulary coverage, expects REMS to soothe payer concerns about appropriate use of the obesity product, he notes.
The advisory committee on Arena Pharmaceuticals’ lorcaserin continues to bring into focus what FDA and its expert advisers expect in terms of cardiovascular safety assessment for weight-loss drugs, possibly signaling a new consensus and the end of years of confusion.
A New England Journal of Medicine study found that FDA is faster in reviewing novel therapeutics than regulatory agencies in Europe and Canada.