Key Regulatory Trends from EMA’s February 2026 CHMP Meeting

The February 2026 meeting of the EMA's Committee for Medicinal Products for Human Use (CHMP) resulted in recommendations for twelve new medicines.¹ These outcomes, which included recommendations for three orphan medicines and six biosimilars, reflect the EMAs focus on addressing unmet medical needs through diverse regulatory pathways.

What Novel Treatment Modalities and Regulatory Pathways Reached Milestones?

One of the most notable advancements is the positive opinion for mCombriax, an influenza and COVID-19 mRNA vaccine developed by Moderna Biotech Spain SL.² As the first combined messenger RNA vaccine designed to protect individuals aged 50 and older against both seasonal influenza and COVID-19, its recommendation underscores the increasing maturity of the mRNA platform. The scalability of such combined vaccines is a critical development in managing significant disease burden in the European economic area, where up to 50 million symptomatic cases of seasonal influenza occur annually.

Regulatory flexibility for high-unmet-need areas was further evidenced by the recommendation of a conditional marketing authorization for Ojemda (tovorafenib) from Ipsen Pharma.¹ Intended for pediatric low-grade glioma in patients as young as 6 months, this once-weekly oral therapy addresses a population for whom existing chemotherapy benefits are often modest and associated with substantial side effects. Similarly, X4 Pharmaceuticals received a positive opinion under exceptional circumstances for Xolremdi (mavorixafor). This treatment is intended for WHIM syndrome, an ultra-rare hereditary condition in which the immune system does not work properly. The CHMP noted that WHIM stands for warts, hypogammaglobulinemia, infections, and myelokathexis. These approvals illustrate how the EMA utilizes specific regulatory frameworks to accelerate access for life-threatening conditions when traditional clinical data sets may be difficult to complete.

Other positive opinions for new chemical entities included Onerji (levodopa / carbidopa) from Tanabe Pharma GmbH for Parkinson's disease, Palsonify (paltusotine) from Crinetics Pharmaceuticals Europe GmbH for acromegaly, and Rhapsido (remibrutinib) from Novartis Europharm Limited for chronic spontaneous urticaria.¹

How Does the Current Pipeline Reflect Shifts in Biosimilar Competition and Therapeutic Extensions?

The continued expansion of the biosimilar market remains a focal point for manufacturing strategy, with the CHMP adopting positive opinions for six biosimilar medicines this month.¹ These include insulin lispro (Bysumlog) and insulin aspart (Dazparda) from Gan & Lee Pharmaceuticals Europe GmbH for the treatment of diabetes. Additional biosimilar recommendations were issued for etanercept (Fubelv) by Biosimilar Collaborations Ireland Limited, pertuzumab (Poherdy) by Organon N.V., tocilizumab (Tuyory) by Chemical Works of Gedeon Richter Plc., and teriparatide (Zandoriah) by Cinnagen Co Unipessoal Lda. The likely entry of these products into the market for conditions ranging from rheumatoid arthritis to breast cancer and osteoporosis indicates a highly competitive landscape for biological manufacturing and development.

Lifecycle management also played a prominent role in the committee's decisions, with six therapeutic extensions recommended.¹ Sanofi Winthrop Industrie received a positive opinion for Dupixent (dupilumab) to treat chronic spontaneous urticaria in children aged 2 to 11 years, making it the first biologic treatment for this specific pediatric population. Furthermore, Dr. Falk Pharma GmbH’s Jorveza was recommended for a pediatric-specific formulation to treat eosinophilic esophagitis. This formulation addresses a critical gap in care, as the current treatment often relies on off-label use of adult formulations.

While many applications succeeded, the committee also issued negative opinions for Daybu by Acadia Pharmaceuticals and iloperidone by Vanda Pharmaceuticals.¹ Additionally, Pfizer Europe MA EEIG withdrew its initial application for sasanlimab, or Zumrad, which was being developed for bladder cancer. These outcomes serve as a reminder of the rigorous clinical evidence requirements maintained by the EMA for securing marketing authorization. Finally, the CHMP issued a positive opinion for Sanofi Winthrop Industrie’s Acoziborole Winthrop under the EU-M4All procedure, a regulatory mechanism that allows the Agency to support public health and regulatory capacity outside the European Union for diseases such as sleeping sickness.³

References

1. European Medicines Agency (EMA). Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23–26 February 2026. Published February 27, 2026. Accessed February 27, 2026. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-february-2026
2. ​European Medicines Agency (EMA). First combined COVID-19 and influenza vaccine for people 50 years and older. Published February 27, 2026. Accessed February 27, 2026. https://www.ema.europa.eu/en/news/first-combined-covid-19-influenza-vaccine-people-50-years-older
3. ​European Medicines Agency (EMA). New single‑dose oral treatment for human African trypanosomiasis (sleeping sickness). Published February 27, 2026. Accessed February 27, 2026. https://www.ema.europa.eu/en/news/new-single-dose-oral-treatment-human-african-trypanosomiasis-sleeping-sickness