EMA CHMP December 2025 Meeting: 7 New Medicine Approvals and 12 Indication Extensions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded its December 8–11, 2025 meeting with positive recommendations for seven new medicines and 12 extensions of indication for existing therapies. These decisions span oncology, respiratory disease, cardiology, infectious disease, immunology, and ophthalmology, reflecting continued momentum in targeted and biologic therapies across Europe

New Medicines Recommended for Approval

Anktiva (nogapendekin alfa inbakicept)

• MAH: ImmunityBio, Inc
• Indication: High-risk non-muscle invasive bladder cancer (NMIBC) in adults
• Regulatory status: Conditional marketing authorisation
• Mechanism: IL-15 superagonist that stimulates natural killer (NK) cells and CD8+ T cells to enhance anti-tumor immune activity
• Key evidence: The pivotal study met its primary endpoint, demonstrating improved complete response rates in patients with limited treatment options

Aumseqa (aumolertinib)

• MAH: SFL Pharmaceuticals Deutschland GmbH
• Indication: EGFR-mutated non-small cell lung cancer (NSCLC)
• Mechanism: Third-generation EGFR tyrosine kinase inhibitor selectively targeting mutant EGFR while sparing wild-type receptors
• Key evidence: Pivotal clinical trial met the primary endpoint of progression-free survival, supporting its role in targeted lung cancer therapy

 Exdensur (depemokimab)

• MAH: GlaxoSmithKline (GSK)
• Indications: Severe eosinophilic asthma and severe chronic rhinosinusitis with nasal polyps
• Mechanism: Ultra-long-acting monoclonal antibody targeting interleukin-5 (IL-5), leading to sustained suppression of eosinophilic inflammation
• Key evidence: Phase 3 trials demonstrated durable asthma control and reduced exacerbations

Myqorzo (aficamten)

• MAH: Cytokinetics
• Indication: Obstructive hypertrophic cardiomyopathy (HCM) in adults
• Mechanism: Selective cardiac myosin inhibitor that reduces excessive myocardial contractility and improves left ventricular outflow
• Key evidence: The SEQUOIA-HCM Phase 3 trial met its primary endpoint, showing clinically meaningful symptom improvement

Mnexspike (COVID-19 mRNA vaccine)

• MAH: ModernaTX, Inc
• Indication: Prevention of COVID-19 in individuals aged 12 years and older
• Mechanism: mRNA vaccine encoding the SARS-CoV-2 spike protein to elicit protective immune responses
• Key evidence: Clinical studies confirmed immunogenicity and vaccine effectiveness against circulating variants

Gotenfia (golimumab biosimilar)

• MAH: STADA / Bio-Thera
• Indications: Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis
• Mechanism: Tumor necrosis factor-alpha (TNF-α) inhibition, reducing inflammatory signaling
• Key evidence: Biosimilarity studies demonstrated equivalent efficacy, safety, and pharmacokinetics compared with the reference product

Ranluspec (ranibizumab biosimilar)

• MAH: Lupin Europe GmbH.
• Indications: Neovascular age-related macular degeneration and other retinal vascular disorders
• Mechanism: VEGF-A inhibition to prevent abnormal blood vessel growth and leakage
• Key evidence: Equivalence trials met primary endpoints for visual acuity outcomes

Extensions of Indication Recommended

CHMP also recommended 12 extensions of indication, expanding the use of established therapies across multiple therapeutic areas. Notable updates include:

• Mounjaro (tirzepatide): Expanded to include adolescents and children aged 10 years and older with type 2 diabetes, alongside diet and exercise
• Arexvy: Broader use of the RSV vaccine
• Aspaveli: Expanded indications in rare complement-mediated disorders
• Eylea: Additional ophthalmic uses
• Nucala: Broadened respiratory indications
• Recarbrio: Expanded antibacterial use
• Simponi and Uplizna: Extended immunology indications
• Winrevair: Expanded use in pulmonary arterial hypertension
• Vueway and Elucirem: Additional imaging and diagnostic applications

• Dovprela: Pulmonary tuberculosis (TB)-related Indication Extension

Detailed product-specific conditions, study data, and marketing authorisation holder information are available in the EMA’s full assessment reports and Q&A documents