Datapoint: Ipsen’s Latest Accelerated Approval Will Challenge Intercept’s Ocaliva

The FDA on June 10 gave accelerated approval to Ipsen Biopharmaceuticals, Inc.’s Iqirvo (elafibranor) in combination with ursodeoxycholic acid for the treatment of adults with primary biliary cholangitis (PBC) who have an inadequate response to UDCA or as a monotherapy in people not able to tolerate UDCA. The agent is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. The FDA gave the medicine breakthrough therapy and orphan drug designations for the rare, autoimmune cholestatic liver disease. Iqirvo will face off against Intercept Pharmaceuticals’ Ocaliva, which was approved for the same PBC indication in 2016. The farnesoid X receptor agonist currently holds covered or better status for 83% of all insured lives under the pharmacy benefit.

SOURCE: MMIT Analytics, as of 6/17/24

0

0

0 Comments

0

0

• Datapoint