Biotech Values

[DewDiligence]

MRK—FDA advisory panel votes 10-5 to reject Vytorin label expansion based on IMPROVE-IT study:

http://www.reuters.com/article/2015/12/14/us-merck-zetia-fda-idUSKBN0TX2IL20151214

Merck & Co should not be allowed to claim that its cholesterol-lowering drug Vytorin reduces the risk of heart attacks and strokes in patients with coronary heart disease, an advisory committee to the U.S. Food and Drug Administration concluded on Monday.

The panel evaluated data from an 18,000-patient trial known as IMPROVE-IT whose results showed that the combination treatment known as Vytorin, comprising Zetia and the older cholesterol-lowering drug simvastatin, reduced the rates of heart attack, stroke and death compared with simvastatin alone.

But panelists were not convinced the benefit was clinically meaningful, especially since some patient data was missing.

From MRK's standpoint, if FDA concurs with the panel, that’s a lot of money spent for nothing. OTOH, Zetia/Vytorin go off-patent in the US in 16 months, so the proposed label expansion wasn't a huge deal in any case.