EMA October drug evaluation meeting: companies such as Sanofi and Insmed have received recommendations for market approval for their new drugs.

At a meeting held this week, the expert group of the European Medicines Agency (EMA) made positive recommendations for the marketing authorization of two new drugs from Sanofi (SNY.US) and Insmed (INSM.US) in the region. The Committee for Medicinal Products for Human Use (CHMP), a subsidiary of EMA, held its meeting from October 13th to 16th, 2025. In addition to recommending the approval of new drugs, the committee also rejected one new drug from Sanofi and recommended 8 new indications for expanded use of drugs. According to the meeting report released by EMA on Friday, Sanofi's Bruton's tyrosine kinase inhibitor, Wayrilz (rilzabrutinib), has received a positive opinion from CHMP and is recommended as a second-line treatment for immune thrombocytopenia. Immune thrombocytopenia is an immune-mediated disease characterized by bleeding. Sanofi stated that this decision was based on the company's pivotal LUNA Phase 3 clinical trial, which met both primary and secondary endpoints. Meanwhile, Insmed's once-daily oral therapy, Brinsupri, also received support from CHMP for the treatment of non-cystic fibrosis bronchiectasis patients aged 12 and older. Non-cystic fibrosis bronchiectasis is a lung disease. If the European Commission, which will be responsible for reviewing the CHMP recommendation, approves the drug, Brinsupri will become the first approved therapy for non-cystic fibrosis bronchiectasis in the region. However, the marketing authorization application for Rezurock submitted by Sanofi for the treatment of chronic graft-versus-host disease (cGVHD) did not receive a positive opinion from CHMP. Chronic graft-versus-host disease is a complication that can occur after stem cell transplantation. Sanofi noted that Rezurock is already marketed in over a dozen countries, including the United States. The company stated that they are disappointed by CHMP's decision and will seek a re-examination of it. Olivier Charmeil, Executive Vice President of Sanofi's Generics division, stated: "We will continue to work closely with the European Medicines Agency to bring this therapy to patients waiting for treatment in the European Union." In terms of expanded indications, the antibody therapy Gazyva (Gazyvaro) co-marketed by Roche (RHHBY.US) and Biogen (BIIB.US) received CHMP support for the treatment of adult patients with specific types of lupus nephritis. Lupus nephritis is a kidney disease. Regeneron Pharmaceuticals, Inc.'s PD-1 immune checkpoint inhibitor Libtayo is expected to receive approval in the EU. CHMP supports the use of this drug as adjuvant treatment for adult patients with cutaneous squamous cell carcinoma after surgery and radiation therapy. The New York-based biotechnology company stated that earlier this month, the drug was approved by the U.S. Food and Drug Administration (FDA) for the same indication. The European Commission is expected to make a final decision on the marketing authorization of the drug in the coming months. In addition, Agios (AGIO.US)'s oral pyruvate kinase activator, Pyrukynd (mitapivat), also received a positive opinion from CHMP for a new indication for the treatment of anemia related to alpha or beta thalassemia in adults. Other companies that received support for expanded indications include Bristol Myers Squibb (BMY.US), Pfizer Inc. (PFE.US), Johnson & Johnson (JNJ.US), and Novartis AG Sponsored ADR Pharmaceuticals (NVS.US).