With today’s advisory committee meeting looming, the sole indication for Intercept Pharmaceuticals’ Ocaliva appears to be at risk as the regulator flags issues regarding its post-marketing results.
Tag Archive for: primary biliary cholangitis
The reviewers, in briefing documents published on the FDA’s website, said the confirmatory trial for the drug did not provide evidence that it was effective in patients with primary biliary cholangitis (PBC).
Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.
Gilead Sciences announced Monday it is acquiring CymaBay Therapeutics and its lead candidate seladelpar, an investigational treatment for primary biliary cholangitis, in a $4.3 billion deal.