The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) convened from October 13 to 16, 2025, to discuss critical healthcare developments. Here are the key takeaways from the meeting.
New Medicines Recommended for Approval
- Brinsupri (brensocatib): This is the first treatment approved for non-cystic fibrosis bronchiectasis, a chronic lung disease. It received support through the PRIority MEdicines (PRIME) scheme, aimed at addressing unmet medical needs.
- Wayrilz (rilzabrutinib): Recommended for treating immune thrombocytopenia in adults who have not responded to other treatments. This disorder leads to low platelet counts and can cause easy bruising and bleeding.
Negative Opinions and Withdrawals
- The committee issued a negative opinion on Rezurock (belumosudil), intended for chronic graft-versus-host disease. This condition occurs when donated cells attack the patient’s organs post-transplant.
- An application for Hydrocortisone Aguettant was withdrawn. This treatment aimed to prevent bronchopulmonary dysplasia in preterm infants, which affects lung development.
Extensions of Therapeutic Indications
The CHMP recommended extensions for eight current therapeutics, enhancing their approved uses:
- Breyanzi
- Cejemly
- Gazyvaro
- Libtayo
- Paxlovid
- Pyrukynd
- Tremfya
- Scemblix
Re-examinations and Suspensions
The committee re-evaluated Austedo (deutetrabenazine) but confirmed its earlier decision to not recognize it as a new active substance for treating adults with moderate-to-severe tardive dyskinesia.
Additionally, the marketing authorization for Oxbryta, a treatment for sickle cell disease, remains suspended following safety reviews initiated in September 2024.
New Administration Routes and Future Steps
The meeting also saw the adoption of a subcutaneous administration route for Saphnelo, a medication used in adult patients with systemic lupus erythematosus, enhancing treatment options.
Looking Ahead
The agenda from this October meeting is accessible on the El-Balad website. The minutes will be available in the following weeks, providing further insights into the committee’s discussions.
