Green light for four new medicines in the EU

The European Medicines Agency (EMA) has recommended four new products for approval, and extended the use of sixteen other drugs. The decisions, which brings to 12 the total number of products approved in 2025, must be formally approved by the European Commission.

At the latest meeting of its key human medicines committee (CHMP), gave its backing to the following:

• Deqsiga (human normal immunoglobulin), intended for replacement therapy in people with primary or secondary immunodeficiencies and immunomodulation in people with certain autoimmune diseases.
• Lynozyfic (linvoseltamab) received conditional authorisation for the treatment of patients with relapsed and refractory multiple myeloma, a cancer of the bone marrow.
• Vyjuvek (beremagene geperpavec) to treat wounds in patients of all ages with dystrophic epidermolysis bullosa, a serious, ultra-rare genetic skin blistering disease caused by mutations in the collagen type VII alpha 1 chain (COL7A1) gene.
• A generic medicine, Trabectedin Accord (trabectedin), received a positive opinion for the treatment of advanced soft tissue sarcoma and of relapsed platinum-sensitive ovarian cancer.

The committee also recommended extending the therapeutic indication of two cystic fibrosis medicines, Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor), to include their use in combination in patients aged two years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The CHMP extended the existing indication of the chikungunya vaccine Ixchiq (chikungunya vaccine (live)) to include the active immunisation of adolescents from 12 years of age. This vaccine was initially approved to protect adults against the disease caused by Chikungunya virus.

Fabhalta (iptacopan) received an extension of indication for the treatment of adult patients with complement 3 glomerulopathy, an ultra-rare kidney disease that previously had no treatment options.

The other 12 extensions of indication for medicines that are already authorised in the EU were: Abrysvo, Calquence, Columvi, Darzalex, Enhertu, Imfinzi, Jaypirca, Prevymis, Rinvoq, Stelara, Supemtek Tetra and Tremfya.