28 February 2025
EMA: Issuance of two recommendations regarding medicinal products
The European Medicine Agency’s (EMA) has issued a recommendation regarding the marketing authorization in the European Union (EU) for Vyjuvek (beremagene geperpavec). Vyjuvek is a treatment for wounds in patients of all ages who suffer from dystrophic epidermolysis bullosa (DEB).
Additionally, EMA’s CHMP issued a positive opinion for the extension of the therapeutic indication of two medicines, Kaftrio (ivacaftor/tezacaftor/elaxacaftor) and Kalydeco (ivacaftor). These medicinal products treat cystic fibrosis and could now be used in combination for patients of two years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
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