MERCK, ASTRAZENECA - Positive recommendation by FDA advisory committee for Use of Vytorin in Predialysis CKD patients: Lipitor generic entry more detrimental to Cres
FDA endocrinologic and metabolic drugs advisory committee unanimously (14-0) recommended approval for Vytorin for reduction of CV risk in pre-dialysis chronic kidney disease patients. The committee’s vote was mixed (10-6 not in favor) for approval in ESRD (end stage renal disease) patients. The USFDA verdict on the Vytorin is expected in 1Q 2012 and if the USFDA endorses, it will rejuvenate clinicians interest in Vytorin and thus help Vytorin differentiate and retain a fair share despite Lipitor generic entry (November 30th). Out of ~24m CKD patients in US, ~15% patients have GFR <=45ml/min (inclusion criteria of SHARP). We forecast $750m in peak sales for Vytorin in the CKD indication.
COMPANIES MENTIONED
Merck and AstraZeneca
Merck and AstraZeneca
