Overview
- Adopted on 16 October 2025, the opinion follows an accelerated assessment supported by EMA’s PRIME scheme.
- Brinsupri is recommended for patients aged 12 and older with non‑cystic fibrosis bronchiectasis who had two or more exacerbations in the previous 12 months.
- In the Phase III ASPEN trial, 25 mg brensocatib cut annualised exacerbations to 1.04 versus 1.29 with placebo (rate ratio 0.81; 95% CI 0.69–0.94) and delayed the median time to first exacerbation by 14 weeks.
- The most common adverse reactions were headache, hyperkeratosis, gingival and periodontal diseases, dermatitis, rash, upper respiratory tract infections and dry skin, and use in pregnancy is not recommended.
- Other CHMP outcomes included a positive opinion for Wayrilz for refractory immune thrombocytopenia, a negative opinion for Rezurock for chronic graft‑versus‑host disease, confirmation of non‑consideration for Austedo as a new active substance, and a recommendation to keep Oxbryta suspended.