Keyword: Intercept Pharmaceuticals
The FDA has scheduled an advisory committee hearing to review Intercept's NASH application, so the company's PDUFA date will have to get pushed back.
With a potential approval next year in the up-and-coming NASH field, Intercept is staffing up its sales team and starting talks with payers.
Intercept presented a data analysis that found treatment with Ocaliva led to "early and consistent improvements" in a range of noninvasive tests.
Initial worries about Ocaliva's safety don't seem to be a problem for doctors now that they have new numbers on its NASH benefits, one analyst says.
Look out, Amgen, Allergan, et al. PBMs are eyeing your forthcoming meds for pricing pressure—and as hep C drugmakers know, consequences can be brutal.
Intercept has been the presumed leader in the NASH drug race, but 19 deaths in current Ocaliva patients pose a threat to those plans.