REMS Cannot Save Abbott's Obesity Drug Meridia In Face Of Cardiovascular Issues
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm withdraws sibutramine as FDA finds no patient group for which risk mitigation would result in sufficient benefit.
You may also be interested in...
Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint
As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.
At Liraglutide Panel Review, A Call For CV Studies To Look Beyond MACE
If cardiovascular studies are required for non-cardiac drugs, they should be focused on specific signals of heart-related concern that may not include ischemic events, advisory committee cardiologists say during review of Novo Nordisk’s Saxenda for obesity.
FDA Gives Metabolism/Endocrinology Division An Acting Director
Diabetes team leader Jean-Marc Guettier is detailed to replace Mary Parks as director of the Division of Metabolism and Endocrinology Products on a temporary basis as she moves up to Deputy Director of the Office of Drug Evaluation II.