Enanta Pharmaceuticals Inc (ENTA)

[NY1972]

Will EMA give MRK a different label? No mention of lower efficacy for GT1a patients who have high VL in FDA label.

EMA nixes “accelerated assessment” of 2-DAA* HCV regimen and will review the application on a standard timetable

above 800,000 IU/mL, the virologic failures were all over the map. one at 948k, 3 between 1-2M iu/ml, 3 between 2-4M, 3 between 4-6M, 3 w VL>6M. So unlike havoni's 8 week trial where they only saw a break point post hoc above 6M baseline VL (constituting the minority of patients), MRK will forever be dogged in the marketplace with a lower efficacy for GT1a, which will be especially pronounced for the majority of GT1a patients who don't have low viral loads. I also think this adds regulatory risk since these pts as i mentioned likely have SVRs below 90%. Recall 8 weeks of Harvoni for pts with VL >6M had 91% SVR and the label only allowed consideration of 8 weeks below this level, so what are they to do with MRK?