FDA Approves IQIRVO — Ipsen Biopharmaceuticals, Inc.

Ipsen Biopharmaceuticals announced on Thursday the U.S. FDA approval of IQIRVO (elafibranor), marking the entry of the first non-bile acid derivative therapy for primary biliary cholangitis and significantly expanding the treatment landscape for patients with ATP synthase complex antibodies. The launch is poised to leverage Ipsen’s established presence in this therapeutic area to challenge current market dominants and capture a share of the growing demand for novel, disease-modifying options.