Intercept’s NASH NDA Positions OCA For May 2020 Approval, Then Launch
Intercept hopes to be first to market in NASH with an indication to treat fibrosis. It also is enrolling a study to show a benefit in NASH patients with cirrhosis.
You may also be interested in...
Intercept announced that the US FDA has set April 22 as date for an advisory committee review of OCA in NASH, meaning March 26 action date could be pushed back as much as three months.
Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.
Atypical histological findings from a Phase IIb NASH study lead CymaBay to terminate mid-stage studies in NASH and PSC and place a Phase III PBC trial on hold.