Lorcaserin Advisory Committee Will Again Be Weighed Down By Safety Concerns
This article was originally published in The Pink Sheet Daily
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will revisit Arena’s obesity drug May 10; readjudication finds fewer cancers in rats than previously identified, but new data fails to rule out the 50% increased risk for valvulopathy sought by FDA.
You may also be interested in...
The Endocrinologic and Metabolic Drugs Advisory Committee votes 18-4, with one abstention, in favor of lorcaserin for long-term treatment of overweight and obese individuals.
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.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.