13 new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its July 2025 meeting.

The committee recommended granting a marketing authorisation for Aqneursa* (levacetylleucine), for the treatment of Niemann-Pick type C, a rare, progressive, fatal genetic disorder caused by mutations encoding lysosomal proteins that are essential for the intracellular transport and metabolism of body fats, including cholesterol. See more details in the news announcement in the grid below.

Ekterly* (sebetralstat) received a positive opinion from the CHMP for the treatment of acute attacks of hereditary angioedema, a rare, chronic, genetic, debilitating, and potentially life-threatening disorder characterised by recurrent and often unpredictable attacks of swelling in many parts of the body. The medicine is administered orally at the earliest sign of an attack. This is the first oral treatment for hereditary angioedema recommended for…