During its May 2024 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended 14 new medicines for approval. Additionally, the committee recommended the extension of therapeutic indications for another seven medicines. The CHMP recommended granting marketing authorization under exceptional circumstances for Adzynma (rADAMTS13), an enzyme replacement therapy for treating children and adult patients with congenital thrombotic thrombocytopenic purpura, a rare and life-threatening blood disorder. Akantior (polyhexanide) received a positive opinion for the treatment of acanthamoeba keratitis, a severe and sight-threatening corneal infection.
A positive opinion was also adopted for Cejemly (sugemalimab) for the treatment of adults with metastatic non-small-cell lung cancer. Durveqtix (fidanacogene elaparvovec), a new gene therapy for hemophilia B, received a recommendation for conditional marketing authorization. This medicine was supported through EMA’s Priority Medicines (PRIME) scheme, aimed at addressing unmet medical needs.
CHMP Approves New Vaccines and Medicines for Various Conditions
Fluenz (influenza vaccine) received a positive opinion for prophylaxis of influenza in children and adolescents aged 24 months to less than 18 years. GalliaPharm (germanium/gallium chloride) was recommended for radiolabelling kits used in positron emission tomography (PET) imaging. Ixchiq (chikungunya vaccine), the first vaccine in the EU to protect adults against the chikungunya virus, also received a positive CHMP opinion. This vaccine was assessed under the OPEN framework and supported through the PRIME scheme.
The CHMP recommended granting marketing authorization for Zegalogue (dasiglucagon) for treating severe hypoglycemia in patients with diabetes mellitus. A biosimilar medicine, Avzivi (bevacizumab), received a positive opinion for treating various types of cancer. Five generic medicines also received positive opinions: Apexelsin (paclitaxel) for metastatic breast cancer, Dasatinib Accord Healthcare (dasatinib) for chronic myelogenous leukemia, and three forms of pomalidomide (Pomalidomide Accord, Pomalidomide Krka, and Pomalidomide Zentiva) for multiple myeloma.
Extensions, Withdrawals, and Re-evaluations of Medicine Authorizations
The committee recommended extensions of indication for seven already authorized medicines: Dupixent, Eliquis, Kinpeygo, Livmarli, Skyrizi, Tagrisso, and Tevimbra. One application for initial marketing authorization for Kinharto, intended for treating adult patients with symptomatic chronic heart failure, was withdrawn. Another application to extend the therapeutic indication of Scenesse for erythropoietic protoporphyria in adolescents was also withdrawn. Following a re-examination, the CHMP confirmed its initial recommendation to refuse marketing authorization for Nezglyal, intended for treating cerebral adrenoleukodystrophy.
The CHMP has restarted the evaluation for renewing the conditional marketing authorization for Translarna (ataluren), used to treat Duchenne muscular dystrophy. The European Commission requested further consideration of the available data and additional real-world data, leading to the convening of a new scientific advisory group on neurology (SAG-N) for Translarna. A revised recommendation is expected in the coming months, with the current marketing authorization still valid. The CHMP completed its assessment of extending the use of the antidepressant Valdoxan to adolescents with moderate to severe depression. Although the application was not pursued, the product information will be updated to include the study results.
Resource: European Medicines Agency, May 31, 2024
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