LDL Hypothesis Brings Out Skeptics, Supporters At FDA Panel
Executive Summary
Agency told advisory committee weighing the IMPROVE-IT data not to debate the LDL-hypothesis; panelists did so anyway.
You may also be interested in...
Keeping Track: FDA Approves Briviact, Refuses To File Firdapse, Rejects Remune
The latest drug development news and highlights from our FDA Performance Tracker.
FDA’s Zetia/Vytorin Rejection Leaves Cholesterol Drug Sponsors In Limbo
FDA’s complete response letter for the cardiovascular risk reduction claim for Zetia/Vytorin was expected, but what will this mean for sponsors of drugs with other mechanisms, like PCSK9?
Does Esperion's Plan For A Statin-Intolerant Claim Have A Shot?
Esperion says it is working with FDA to forge a new regulatory path for its cholesterol drug ETC-1002 in statin-intolerant patients – a population the agency has been very cautious about in the past.