EMA Greenlights Wave of New Medicines, Including First Combined Flu & COVID Vaccine
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 12 new medicines, marking a significant step forward in addressing a range of health challenges. Among the most notable is mCombriax, a first-of-its-kind mRNA vaccine offering combined protection against influenza and COVID-19 for individuals aged 50, and older.
The Rise of Combination Vaccines
mCombriax represents a pivotal moment in vaccine technology. With over 281 million reported cases of COVID-19 in Europe as of February 1, 2026, and up to 50 million symptomatic cases of seasonal influenza annually in the European Economic Area, the need for broad-spectrum respiratory protection is clear. This combination approach simplifies vaccination schedules and potentially improves public health outcomes by increasing compliance. Moderna’s CEO, Stéphane Bancel, highlighted the potential of combination vaccines to “simplify vaccination and support improved health outcomes.”
Targeting Rare and Complex Diseases
Beyond respiratory illnesses, the CHMP’s recommendations address critical needs in rare and complex disease management. Ojemda, a new once-weekly oral therapy, offers hope for patients with paediatric low-grade glioma, a type of non-cancerous brain tumour. Current treatments, like chemotherapy, often have limited benefits and significant side effects. Similarly, Xolremdi received a positive opinion under exceptional circumstances for the treatment of WHIM syndrome, a debilitating ultra-rare hereditary condition impacting the immune system.
Advances in Established Therapies
The committee also endorsed positive opinions for several medicines addressing established conditions. Onerji aims to improve the lives of adults with advanced Parkinson’s disease, while Palsonify offers a new treatment option for acromegaly, a rare hormonal disorder. Rhapsido received a positive opinion for chronic spontaneous urticaria, a long-term itchy rash. Extensions of therapeutic indications were recommended for Dupixent, Jorveza, Keytruda, Olumiant, Scemblix, and Stelara, broadening their applicability and potential impact.
Biosimilars Expand Access to Essential Medicines
The approval of six biosimilar medicines – Bysumlog and Dazparda (insulin), Fubelv (etanercept), Poherdy (pertuzumab), Tuyory (tocilizumab), and Zandoriah (teriparatide) – is expected to increase access to vital treatments for conditions like diabetes, rheumatoid arthritis, breast cancer, and osteoporosis. Biosimilars offer cost-effective alternatives to originator biologics, potentially reducing healthcare burdens.
Global Health Initiatives: Tackling Neglected Tropical Diseases
The CHMP’s positive opinion for Acoziborole Winthrop, a single-dose oral treatment for human African trypanosomiasis (sleeping sickness), underscores the EMA’s commitment to global health. This medicine, developed under the EU-Medicines for all (EU-M4All) initiative, simplifies treatment and accelerates access for patients in affected regions.
Not All Approvals Guaranteed: Setbacks and Withdrawals
The CHMP process isn’t without its challenges. Negative opinions were issued for Daybu (trofinetide) for Rett syndrome and Iloperidone Vanda Pharmaceuticals (iloperidone) for schizophrenia and bipolar disorder, highlighting the rigorous standards for drug approval. The application for Zumrad (sasanlimab), a potential treatment for bladder cancer, was withdrawn.
Future Trends in Pharmaceutical Approvals
These recent CHMP recommendations point to several emerging trends in pharmaceutical development and regulatory approval:
- Personalized Medicine: The focus on rare diseases and targeted therapies like Ojemda suggests a growing emphasis on personalized medicine approaches.
- Combination Therapies: mCombriax exemplifies the trend towards combination therapies, offering broader protection and potentially improved patient adherence.
- mRNA Technology: The success of mRNA vaccines for COVID-19 is driving innovation in this field, with potential applications beyond infectious diseases.
- Biosimilar Competition: The increasing number of biosimilar approvals will likely continue to drive down healthcare costs and improve access to essential medicines.
- Global Health Collaboration: Initiatives like EU-M4All demonstrate a growing commitment to addressing global health challenges and ensuring access to medicines in underserved populations.
Did you know?
The CHMP is responsible for the scientific evaluation of applications for marketing authorizations for medicines in the EU. Its recommendations are then sent to the European Commission for a final decision.
Frequently Asked Questions
- What is the CHMP? The Committee for Medicinal Products for Human Use, responsible for recommending new medicines for approval in the EU.
- What is mCombriax? A first-in-class combination mRNA vaccine protecting against both influenza and COVID-19.
- What does a “positive opinion” indicate? It means the CHMP recommends the European Commission approve the medicine.
- What are biosimilars? Cost-effective alternatives to originator biologic medicines with comparable efficacy and safety.
Stay informed about the latest developments in pharmaceutical approvals and their impact on healthcare. Explore our other articles on vaccine technology and rare disease treatments.
