Lyvdelzi (seladelpar)

pCPA File Number: 23441
Negotiation Status:
Active Negotiation
Indication(s):
For the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in adults unable to tolerate UDCA.
Sponsor/Manufacturer:
Gilead Sciences Canada Inc.
CDA-AMC Project Number:
SR0899-000
pCPA Engagement Letter Issued:
Negotiation Process Concluded:
Not Applicable