'Clean Label' For Intercept's Ocaliva In PBC Bodes Well For NASH Claim
Executive Summary
By determining a safe dosing regimen for Child-Pugh B and C patients, FDA was able to provide a label almost completely without contraindications despite safety concerns about liver-related adverse reactions.
You may also be interested in...
CymaBay’s Stalled Seladelpar Back In Play For PBC
Weeks after lifting of an FDA clinical hold, CymaBay says it will resume development of its PPAR agonist in primary biliary cholangitis. It will initiate a new Phase III trial but also use data from a terminated Phase III study.
Genfit Not Fully Exiting NASH, Despite Terminating RESOLVE-IT
A fuller look at interim Phase III data shows no path forward to accelerated approval in NASH, company says. Genfit turns focus to developing elafibranor for PBC, as well as a NASH diagnostic.
Could Postponement of Intercept’s Expected NASH Panel Impact Its PDUFA Date?
CDER’s postponing of meetings planned through the end of April likely means a later advisory committee date to review OCA in NASH. The US PDUFA date previously was pushed back to late June.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: