EMA backs seven new medicines and 11 expanded treatment indications
EMA’s committee on human medicines has recommended seven new medicines for approval and expanded indications for 11 existing treatments at its November 2026 meeting
The European Medicines Agency’s (EMA) human medicines committee has recommended seven new medicines for approval and expanded indications for 11 existing treatments following its 9–12 November meeting.
The Committee for Medicinal Products for Human Use (CHMP) recommended Aumseqa (aumolertinib) for non-small cell lung cancer, Baxfendy (baxdrostat) for insufficiently controlled hypertension and Zybrivo (sintilimab) for non-squamous non-small cell lung cancer in adults.
Two insulin aspart biosimilars, Garzulys and Donrafylix, also received positive opinions for diabetes mellitus in adults, adolescents and children aged one year and older, potentially expanding treatment access.
The committee also backed the generic medicines Fondaparinux sodium (Evumed), an anticoagulant, and Ruxolitinib (Krka), used to treat certain blood disorders.
New class of treatment for hypertension “triumph of science”
Among the highlights, AstraZeneca's Baxfendy could offer a new treatment option for patients whose blood pressure remains elevated despite use of existing medicines. Around 70 million European adults have uncontrolled hypertension despite treatment, increasing their cardiovascular risk.
Dr Bryan Williams, Chair of Medicine at University College London and principal investigator, described the research behind Baxfendy as a “triumph of science”, highlighting its potential as a new class of treatment.
"Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events like heart attack and stroke, underscoring why effective blood pressure lowering matters for people living with uncontrolled hypertension."
Meanwhile, Roche’s Gazyvaro (obinutuzumab) was among 11 existing medicines recommended for expanded indications, including systemic lupus erythematosus (SLE).
“Many people with systemic lupus erythematosus experience recurring flares, progressive organ damage, and chronic steroid dependence,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. He added that the recommendation brings Gazyvaro closer to offering patients “meaningful and sustained disease control”.
Other medicines recommended for indication extensions included Bexsero (meningococcal disease), Cosentyx (inflammatory diseases), Dovato (HIV infection), Enflonsia (RSV infection), Isturisa (Cushing’s syndrome), Steglatro (type 2 diabetes), Sunlenca (HIV infection), Talzenna (breast and prostate cancer), Tivicay (HIV infection) and Welireg (kidney cancer and certain rare tumours), potentially broadening treatment options across several diseases.
The CHMP also maintained its refusals for KemSu (acute pain in children and adolescents) and Meplyffa (Niemann-Pick disease type C), while marketing authorisation applications for Amlypave (kappa light chain amyloidosis) and Qezzaqar (leiomyosarcoma and synovial sarcoma) were withdrawn.
Positive CHMP recommendations require final European Commission decisions before the proposed EU authorisations or indication extensions can take effect.