Sanofi(US:SNY) 智通财经网·2025-10-17 13:34Core Insights - The European Medicines Agency (EMA) has provided positive recommendations for new drug approvals from Sanofi (SNY.US) and Insmed (INSM.US) during its recent meeting [1][2] - Sanofi's drug Wayrilz (rilzabrutinib) has been recommended for the treatment of immune thrombocytopenia, while Insmed's Brinsupri is supported for treating non-cystic fibrosis bronchiectasis in patients aged 12 and older [1][2] - Sanofi's application for Rezurock for chronic graft-versus-host disease (cGVHD) was not positively reviewed, prompting the company to seek a re-evaluation [2] Sanofi - Wayrilz has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) based on the successful LUNA Phase 3 clinical trial [1] - The company expressed disappointment over the negative opinion for Rezurock, which is already available in several countries including the U.S. [2] - Sanofi's executive vice president stated the commitment to work closely with EMA to bring the therapy to EU patients [2] Insmed - Brinsupri, an oral therapy, is poised to become the first approved treatment for non-cystic fibrosis bronchiectasis in the EU if the European Commission approves the CHMP recommendation [1] Other Companies - Roche (RHHBY.US) and Biogen (BIIB.US) received CHMP support for Gazyva (Gazyvaro) for treating specific types of lupus nephritis [2] - Regeneron Pharmaceuticals (REGN.US) is expected to gain EU approval for Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma [2] - Agios (AGIO.US) received a positive opinion for Pyrukynd (mitapivat) for treating anemia related to adult α or β thalassemia [3] - Other companies with supported indication expansions include Bristol-Myers Squibb (BMY.US), Pfizer (PFE.US), Johnson & Johnson (JNJ.US), and Novartis (NVS.US) [3]