The Committee for Medicinal Products for Human Use (CHMP) has issued landmark recommendations, paving the way for advanced medicines and vaccines to enter the European market. Most notably, the committee approved a combination vaccine and therapies for tropical and rare diseases.
Highlights in Combo Vaccines and Parasitic Treatments
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“2-in-1” Vaccine: Moderna’s mCombriax received a positive opinion for individuals aged 50 and older. It stands as the world’s first mRNA vaccine to protect against both seasonal influenza and COVID-19 in a single shot, marking a shift from the initial regulatory hesitation seen in the U.S.
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Sleeping Sickness Breakthrough: Acoziborole (co-developed by Sanofi and DNDi) was recommended as a single-dose oral treatment for African sleeping sickness. This represents a massive leap from previous 10-day regimens or highly toxic arsenic-based injections.
Expanding Treatment for Specific Conditions The CHMP also issued favorable opinions for several other medications:
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Chronic Hives: Remibrutinib (Novartis) and Dupixent (Sanofi) were recommended for adults and children with chronic spontaneous urticaria who do not respond to antihistamines.
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Oncology and Endocrinology: Ojemda was proposed for pediatric low-grade glioma; Palsonify for acromegaly; and Xolremdi for the ultra-rare WHIM syndrome.
Notable Rejections Despite being available in the U.S., two drugs—the antipsychotic Iloperidone and the Rett syndrome medication Daybu—were rejected by the CHMP due to concerns over cardiovascular risks and insufficient evidence of efficacy.