New medicines recommended for approval by CHMP in April 2025
The European Medicines Agency’s (EMA)) human medicines committee (CHMP) has recommended seven novel medicines for approval at its April 2025 meeting. A final decision from the European Commission is usually issued in about two months.
The CHMP recommended granting a marketing authorization for Vertex Pharmaceuticals’ (Nasdaq: VRTX) Alyftrek (deutivacaftor / tezacaftor / vanzacaftor), a medicine intended for the treatment of cystic fibrosis in people aged six years and older who have at least one non class I mutation in the cystic fibrosis transmembrane conductance regulator gene. Cystic fibrosis is an inherited disease that damages the lungs, the digestive system and other organs.
A positive opinion was adopted for Purpose Pharma International’s Attrogy (diflunisal), for the treatment of hereditary transthyretin-mediated amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.
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