Full Breakdown
EMA's CHMP Meeting Highlights: New Approvals and Rejections
10/17/2025, 8:46:38 PM
New Medicines Recommended for Approval
During its meeting from October 13 to 16, 2025, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval. The first, Brinsupri (brensocatib), is the inaugural treatment for non-cystic fibrosis bronchiectasis, a chronic lung disease characterized by damaged airways and severe pulmonary dysfunction. This recommendation was supported through the EMA's PRIority MEdicines (PRIME) scheme, which aims to expedite access to promising treatments addressing unmet medical needs. The second medicine, Wayrilz (rilzabrutinib), was recommended for treating immune thrombocytopenia in adult patients who have not responded to other therapies. This condition leads to low platelet counts, resulting in increased bruising and bleeding.
Negative Opinion for Rezurock
In contrast, the CHMP issued a negative opinion regarding Rezurock (belumosudil), intended for the treatment of chronic graft-versus-host disease (cGVHD). This condition arises when donor cells attack the recipient's organs post-transplant. The committee found it challenging to quantify Rezurock's efficacy compared to existing treatments, noting that a study did not demonstrate beneficial effects when used as a first-line treatment. Sanofi, the manufacturer, plans to seek a re-examination of this decision, expressing confidence in the drug's safety and efficacy based on clinical and real-world evidence.
Extensions of Therapeutic Indications
The CHMP also recommended extensions of therapeutic indications for eight existing medicines, including Paxlovid (Pfizer), Tremfya (Johnson & Johnson), and Libtayo (Regeneron). These extensions aim to enhance the approved uses of these therapies, reflecting ongoing evaluations of their effectiveness in treating various conditions.
Re-examinations and Suspensions
The committee confirmed its earlier decision regarding Austedo (deutetrabenazine), maintaining that it would not be recognized as a new active substance for treating 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.
Official Statements & Responses
Sanofi's Executive Vice President, Olivier Charmeil, expressed disappointment over the negative opinion for Rezurock, stating, “We will continue to work closely with the European Medicines Agency with the aim of bringing this treatment to patients in the EU who are waiting.” He emphasized the importance of Rezurock for patients suffering from cGVHD.
What's Next
The CHMP's agenda and minutes from the October meeting will be published on the EMA's website in the coming weeks, providing further insights into the committee's discussions and future steps regarding the reviewed medicines.
