CHMP January 2026 Approvals: Expanding Access to Innovative Therapies
CHMP January 2026 Approvals Signal Expanded Access to Innovative Therapies
The CHMP January 2026 approvals from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meeting (26-29 January 2026) recommended six new medicines, one following re-examination, and extensions for nine existing therapies. These CHMP January 2026 approvals mark robust advancements in treatment options across rare diseases, metabolic disorders, and supportive care. Key highlights include first approvals for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis and thymidine kinase 2 deficiency, plus a new influenza vaccine aligned with World Health Organization (WHO) guidelines. Outcomes underscore CHMP’s commitment to unmet needs while scrutinizing data integrity for Tavneos (avacopan).
Breakthroughs for Rare Genetic and Metabolic Disorders
CHMP’s positive opinions for novel therapies deliver significant breakthroughs, especially for orphan indications without prior authorised treatments. Kygevvi (doxecitine / doxribtimine) earned a recommendation under exceptional circumstances as the first therapy for thymidine kinase 2 deficiency (TK2d), a rare genetic disorder impairing muscle function and life expectancy in patients symptomatic by age 12; this PRIME-supported medicine shifts from supportive care like ventilators to targeted intervention. Kayshild (semaglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist, received conditional marketing authorisation for non-cirrhotic MASH with F2-F3 fibrosis—the first in its class—building on GLP-1 uses in diabetes and obesity. Endorsements, backed by orphan designations for Kygevvi and Rezurock (belumosudil) post-re-examination for chronic graft-versus-host disease, emphasize evidence from specialised studies showing clinical benefit where alternatives fail.
Oncology and Anaphylaxis Expansions Boost Precision Care
Extensions broaden access, with Zynyz (retifanlimab)—an orphan-designated immunotherapy—recommended for unresectable metastatic or recurrent squamous cell carcinoma of the anal canal (SCAC), covering 85% of anal cancers lacking prior EU-specific authorisations. Eurneffy (epinephrine) gained approval for a new 1 mg nasal spray in children weighing 15-30 kg, innovating non-injectable emergency anaphylaxis treatment. Seven more extensions for Akeega, Efmody, Iclusig, Imfinzi, Kerendia, Noxafil, and Opdivo enhance adaptive use in oncology, endocrinology, and infectious diseases, supported by post-authorisation data.
Data Integrity Probes and Product Updates
CHMP initiated a referral for Tavneos (avacopan) under Article 20 of Regulation (EC) No 726/2004 due to data integrity issues in its pivotal study for granulomatosis with polyangiitis and microscopic polyangiitis, following a European Commission request. While denying a new indication for Mounjaro (tirzepatide) in chronic heart failure with preserved ejection fraction (HFpEF) in obese adults, CHMP added supportive study data to product information for transparency alongside weight management uses. Other approvals include Fylrevy (estetrol) for menopausal symptoms, Ilumira (lutetium (177Lu) chloride) as a radiopharmaceutical precursor, and Supemtek influenza vaccine via targeted evaluations and WHO-aligned compositions.
HEOR Impacts on Reimbursement and Access
These CHMP January 2026 approvals will influence reimbursement via expanded indications for high-cost GLP-1 agonists and immunotherapies. Conditional nods for Kayshild and Rezurock may speed payer deals through risk-sharing, balancing innovation and budgets in metabolic and transplant care. Orphan statuses for Kygevvi and Zynyz enable premium pricing under EU incentives. Tavneos uncertainty could delay access and prompt cost-effectiveness reviews for vasculitis.
