www.ema.europa.eu
Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its October 2025 meeting.
The committee recommended granting a marketing authorisation for Brinsupri (brensocatib), the first treatment for non-cystic fibrosis bronchiectasis, a serious, chronic, progressive lung disease resulting in damaged airways and severe pulmonary dysfunction, often leading to chronic cough and airflow obstruction due to abnormal mucus production. It was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below.
A positive opinion was adopted for Wayrilz (rilzabrutinib) [footnote], for the treatment of immune thrombocytopenia in adult patients who are refractory to other treatments. Immune thrombocytopenia is a long-term condition…
