Alfasigma’s PBC Treatment Ocaliva to Face FDA Advisory Committee in September

Upcoming FDA Advisory Committee Meeting:
Alfasigma's treatment for primary biliary cholangitis (PBC), Ocaliva, will be discussed at an FDA advisory committee meeting in September 2024.

Supplemental New Drug Application (sNDA):
The FDA has accepted a supplemental New Drug Application (sNDA) for Ocaliva, which includes data from post-marketing studies and real-world evidence to confirm clinical benefits in PBC patients.

PDUFA Target Action Date:
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024, for the sNDA.

Safety Concerns:
The FDA has restricted the use of Ocaliva in PBC patients with advanced cirrhosis due to the risk of serious liver injury, including liver failure and the need for liver transplants.

Clinical Benefits:
Ocaliva has shown improvements in liver tests and has been indicated for PBC patients without advanced cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension.