PARIS (dpa-AFX) - At its February 2026 meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted positive opinions for Moderna's combined COVID-19 -Influenza vaccine, Sanofi's single-dose therapy for Human African trypanosomiasis, and Ipsen's targeted treatment for pediatric low-grade glioma, moving the therapies a step closer to European approval.
Moderna Inc. (MRNA)
On February 27, 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, recommended marketing authorization for Moderna's mCOMBRIAX, a combination vaccine indicated for COVID-19 and influenza vaccine for people 50 years and older.
mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion and represents Moderna's fourth vaccine to receive a positive CHMP opinion.
The European Commission will consider the recommendation and is expected to adopt a final decision on the marketing authorization. The adoption of the decision should take place within 67 days of the recommendation.
Upon approval, the marketing authorization of the European Commission will be valid in all EU Member States as well as in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.
Sanofi (SNY)
On February 27, 2026, the European Medicines Agency's CHMP adopted a positive opinion on Acoziborole Winthrop for the treatment of human African trypanosomiasis, also known as sleeping sickness.
The human African trypanosomiasis is spread through the bite of tsetse flies infected with the parasite Trypanosoma brucei gambiense.
Acoziborole is the first single-dose oral treatment for both stages of T.b. gambiense sleeping sickness, the most common form of the disease, in adults as well as in adolescents 12 years and older weighing at least 40 kilograms.
Drugs for Neglected Diseases initiative (DNDi), a not-for-profit medical research organization, and Sanofi are collaborating in the development of Acoziborole Winthrop.
Ipsen (IPSEY)
On February 27, 2026, Ipsen's Ojemda received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending conditional marketing authorization to treat children aged six months and older with relapsed or refractory pediatric low-grade glioma, a brain tumor driven by BRAF alterations.
Ipsen licensed the ex-US rights to Ojemda from Day One Biopharmaceuticals Inc. (DAWN) in 2024.
Following the positive opinion, the European Commission will review the CHMP recommendation, with a final decision expected in the coming months.
If approved, Ojemda is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alteration.
In the U.S., Ojemda was granted accelerated approval by the FDA for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation in April 2024.
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