EMA Approves First Treatment for Non-Cystic Fibrosis Bronchiectasis as 16 New Medicines Receive Marketing Authorization
核心洞察
The European Medicines Agency (搜索)'s CHMP (搜索) recommended approval for Brinsupri (搜索) (brensocatib), marking the first treatment specifically for non-cystic fibrosis bronchiectasis, a serious chronic lung disease.
A total of 16 medicines received positive opinions across September and October 2025 meetings, including treatments for RSV prevention, myasthenia gravis, and immune thrombocytopenia.
Nine biosimilar medicines for conditions including osteoporosis and rheumatoid arthritis were approved, expanding treatment access across Europe.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP (搜索)) has recommended approval for 16 new medicines across its September and October 2025 meetings, including the first treatment specifically indicated for non-cystic fibrosis bronchiectasis.
Breakthrough Treatment for Rare Lung Disease
The committee granted marketing authorization for Brinsupri (搜索) (brensocatib), representing a significant milestone as the first treatment for non-cystic fibrosis bronchiectasis. This serious, chronic, progressive lung disease results in damaged airways and severe pulmonary dysfunction, often leading to chronic cough and airflow obstruction due to abnormal mucus production. The medicine was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines addressing unmet medical needs.
Major Approvals for Critical Conditions
The CHMP (搜索) recommended Enflonsia (搜索) (clesrovimab) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. RSV is a common respiratory virus that usually causes cold-like symptoms but can affect the lungs. Almost all children contract RSV by age two, and while most recover quickly, some children develop severe illness requiring hospitalization and potentially leading to death.
For neurological conditions, the committee approved Imaavy (nipocalimab) for treating generalized myasthenia gravis, a disease causing muscle weakness and tiredness. Additionally, Wayrilz (rilzabrutinib) received approval for immune thrombocytopenia in adult patients refractory to other treatments. This long-term condition involves the immune system destroying healthy platelets, leading to low platelet counts and increased bleeding risk.
Diabetes and Menopause Treatment Options
Kyinsu (搜索) (insulin icodec/semaglutide) gained approval for adults with type 2 diabetes insufficiently controlled on basal insulin or GLP-1 receptor agonists. The treatment is used alongside diet, exercise, and oral diabetes medications. For menopausal symptoms, Lynkuet (elinzanetant) received authorization for treating moderate-to-severe vasomotor symptoms, including hot flushes and night sweats.
Expanded Biosimilar Access
The committee approved nine biosimilar medicines, significantly expanding treatment access. Four denosumab biosimilars—Acvybra, Denosumab Intas, Kefdensis, and Ponlimsi—received approval for osteoporosis and bone loss treatment. Three additional denosumab biosimilars—Degevma, Xbonzy, and Zvogra—were approved for preventing skeletal-related events and treating giant cell tumor of bone.
Gobivaz (golimumab) gained approval for multiple inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis. Usgena (ustekinumab) received authorization for Crohn's disease, plaque psoriasis, pediatric plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Safety Concerns and Suspensions
The committee maintained the suspension of Oxbryta for sickle cell disease, following interim measures implemented in September 2024 to review emerging safety data. Sickle cell disease is a genetic condition where individuals produce abnormal hemoglobin, causing red blood cells to become rigid, sticky, and crescent-shaped rather than disc-shaped.
The CHMP (搜索) also recommended against granting marketing authorization for Rezurock (belumosudil), intended for chronic graft-versus-host disease treatment, where donor cells attack the body's organs after transplant.
Therapeutic Indication Extensions
The committee recommended extending therapeutic indications for 14 medicines already authorized in the EU, including Uplizna (inebilizumab) for active immunoglobulin G4-related disease, a rare autoimmune condition currently lacking authorized treatments in Europe. Other extensions covered medicines including Breyanzi, Cejemly, Gazyvaro, Libtayo, Paxlovid, and Tremfya.
Application Withdrawals
Five applications for initial marketing authorization were withdrawn, including Amtagvi (lifileucel) for unresectable or metastatic melanoma, Fanskya (mozafancogene autotemcel) for Fanconi Anemia Type A, and two midazolam formulations for seizure treatment and sedation.