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 in which the body’s immune system destroys healthy platelets in the blood. Platelets are needed to form clots and stop bleeding. Patients with the disease have low platelet counts and may bruise or bleed easily.
Negative opinion for one medicine
The committee recommended not granting a marketing authorisation for Rezurock (belumosudil) [footnote], a medicine intended for the treatment of chronic graft-versus-host disease, a condition in which donor cells attack the body’s organs after a transplant.
For more information on this negative opinion, see the question-and-answer document in the grid below.
Recommendations on extensions of therapeutic indication for eight medicines
The committee recommended extensions of indication for eight medicines that are already authorised in the EU: Breyanzi, Cejemly, Gazyvaro, Libtayo, Paxlovid, Pyrukynd [footnote], Tremfya and Scemblix.
Withdrawal of applications
An application for an initial marketing authorisation was withdrawn. Hydrocortisone Aguettant (hydrocortisone) was developed to prevent bronchopulmonary dysplasia in preterm (premature) infants between 24 and 28 weeks of postmenstrual age (after the mother’s last menstruation). Bronchopulmonary dysplasia is a chronic (long-term) lung disease affecting preterm infants who have been on prolonged mechanical ventilation (a machine that supplies oxygen to help with breathing).
A question-and-answer document on the withdrawal of this medicine is available in the grid below.
Outcome of re-examination
Following a re-examination at the request of the applicant for Austedo (deutetrabenazine), a medicine for the treatment of adults with moderate-to-severe tardive dyskinesia, the committee confirmed its initial recommendation to not consider deutetrabenazine, as a new active substance.
Conclusion of referral
The committee has recommended that the marketing authorisation of the sickle cell disease medicine Oxbryta remains suspended. This recommendation follows interim measures taken by the committee in September 2024, when it temporarily suspended the medicine to review emerging safety data. Sickle cell disease is a genetic disease where individuals produce an abnormal form of haemoglobin (the protein in red blood cells that carries oxygen). The red blood cells become rigid and sticky and change from being disc-shaped to being crescent-shaped (like a sickle).
For more information on this recommendation, see the public health communication in the grid below.
Other updates
The committee adopted a new subcutaneous route of administration for Saphnelo, a medicine used as an add-on treatment in adults with systemic lupus erythematosus, a disease in which the immune system attacks normal cells and tissues, causing inflammation and organ damage.
Agenda and minutes
The agenda of the October 2025 CHMP meeting is published on EMA’s website. Minutes of the meeting will be published in the coming weeks.
Footnote: This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
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