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EMA Recommends 12 New Medicines for Approval, Including Combined COVID-19/Flu Vaccine

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EMA February 2026 Meeting Overview

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) concluded its February 2026 meeting with significant recommendations. The CHMP recommended 12 new medicines for approval, spanning a wide range of medical areas. These include infectious diseases, neurological disorders, rare conditions, and chronic illnesses.

Key Positive Recommendations

The CHMP adopted positive opinions for several innovative new medicines, poised to address critical unmet needs across various therapeutic areas:

  • mCombriax (influenza and COVID-19 mRNA vaccine): This groundbreaking vaccine received a recommendation for marketing authorization. It is the first combined messenger RNA vaccine designed to protect individuals aged 50 years and older against both COVID-19 and seasonal influenza. The need for such a vaccine is underscored by World Health Organization (WHO) data, indicating over 281 million COVID-19 cases in Europe by February 1, 2026, alongside up to 50 million annual seasonal influenza cases in the European Economic Area (EEA).

  • Ojemda (tovorafenib): Recommended for conditional marketing authorization, Ojemda offers a new once-weekly oral therapy for patients aged six months and older with pediatric low-grade glioma, a type of non-cancerous brain tumor.

  • Onerji (levodopa / carbidopa): Received a positive opinion for the treatment of advanced Parkinson's disease in adults.

  • Palsonify (paltusotine): Recommended for the treatment of acromegaly, a rare hormonal disorder resulting from excess growth hormone.

  • Rhapsido (remibrutinib): Received a positive opinion for the treatment of chronic spontaneous urticaria, a long-term itchy rash.

  • Xolremdi (mavorixafor): This medicine received a positive opinion under exceptional circumstances for WHIM syndrome, an ultra-rare hereditary immune system disorder that heightens susceptibility to infections. It is intended for patients 12 years of age and older.

Biosimilar Approvals

Six biosimilar medicines also received positive opinions, offering alternative treatment options for established conditions and potentially increasing patient access:

  • Bysumlog (insulin lispro) and Dazparda (insulin aspart): Both recommended for the treatment of diabetes.
  • Fubelv (etanercept): Approved for a range of inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and pediatric plaque psoriasis.
  • Poherdy (pertuzumab): Recommended for the treatment of breast cancer.
  • Tuyory (tocilizumab): Received approval for multiple conditions such as rheumatoid arthritis, COVID-19, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, CAR-T cell-induced severe or life-threatening cytokine release syndrome, and giant cell arteritis.
  • Zandoriah (teriparatide): Recommended for the treatment of osteoporosis.

International Public Health Initiative

Demonstrating its commitment to global health, the CHMP also issued a positive opinion for a medicine intended for use outside the EU:

  • Acoziborole Winthrop (acoziborole): This medicine was recommended as a single-dose oral treatment for human African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense.

This approval was part of the EU-Medicines for all (EU-M4All) procedure, an initiative designed to support global regulatory capacity building and public health efforts beyond the EU.

Negative Recommendations

The CHMP also concluded its review of two medicines with a negative recommendation, advising against granting marketing authorization:

  • Daybu (trofinetide): Intended for the treatment of Rett syndrome.
  • Iloperidone Vanda Pharmaceuticals (iloperidone): Intended for the treatment of schizophrenia and acute manic or mixed episodes associated with bipolar disorder.

Extended Indications for Existing Medicines

Six existing medicines received recommendations for extended therapeutic indications, broadening their use and impacting more patient populations:

  • Dupixent (dupilumab): Its indication was extended for chronic spontaneous urticaria in children aged 2 to 11 years, marking it as the first biologic treatment available for this pediatric age group.
  • Jorveza (budesonide): Received an extension for eosinophilic oesophagitis in patients aged 2 to 17 years. This recommendation includes a new pediatric-specific formulation, directly addressing a significant unmet medical need.
  • Additionally, Keytruda, Olumiant, Scemblix, and Stelara received recommendations for other extensions of indication, further expanding their therapeutic reach.

Application Withdrawal

An application for initial marketing authorization for Zumrad (sasanlimab), which was intended for bladder cancer, was withdrawn during the meeting.