IMPROVE-IT Study: Negative Panel Review Leaves FDA With Tough Choice
Approval of cardiovascular risk reduction claims for Merck's Zetia and Vytorin would fly in the face of advisory committee's recommendations, but rejection would mean the first outcomes study to show CV benefit for a non-statin, LDL-C-lowering agent did not provide substantial evidence.
You may also be interested in...
The latest drug development news and highlights from our FDA Performance Tracker.
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?
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.