EMA’s CHMP backs two novel medicines approvals
The European Medicine Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its October 2025 meeting.
The committee recommended granting a marketing authorization for USA-based Insmed’s (Nasdaq: INSM) 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.
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