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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025

Two new medicines recommended for approval; another eight medicines recommended for extension of their therapeutic indications
News Human Medicines

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An application for an initial marketing authorisation was withdrawn.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.

CHMP statistics

CHMP highlights - October 2025

October 2025 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:

  • 2 positive opinions on new medicines: 1 new non-orphan medicine, 1 orphan medicine, 0 biosimilars, and 0 generic, hybrid or informed consent medicine. Total in 2025: 87

  • 1 negative opinions on new medicines. Total in 2025: 6

  • 8 positive opinions on extensions of therapeutic indication. Total in 2025: 73

  • 1 withdrawn applications for new medicines. Total in 2025: 18

Positive recommendations on new medicines

Brinsupri

International non-proprietary name (INN)

brensocatib

Marketing authorisation applicant

Insmed Netherlands B.V.

Therapeutic indication

Treatment of non-cystic fibrosis bronchiectasis

More information

Wayrilz

International non-proprietary name (INN)

rilzabrutinib

Marketing authorisation applicant

Sanofi B.V.

Therapeutic indication

For the treatment of immune thrombocytopenia in adult patients who are refractory to other treatments. 

More information

Negative recommendation on new medicine

Rezurock

INN

belumosudil

Marketing authorisation applicant

Sanofi Winthrop Industrie

Therapeutic indication

Treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy

More information

Outcome of re-examination on recommendation for new medicine

Austedo

INN

deutetrabenazine

Marketing authorisation applicant

Teva GmbH

Therapeutic indication

Treatment of tardive dyskinesia

More information

Positive recommendations on extensions of therapeutic indications

Breyanzi

INN

lisocabtagene maraleucel / lisocabtagene maraleucel 

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG

More information

Cejemly

INN

sugemalimab

Marketing authorisation holder

Cstone Pharmaceuticals Ireland Limited

More information

Gazyvaro

INN

obinutuzumab

Marketing authorisation holder

Roche Registration GmbH

More information

Libtayo

INN

cemiplimab

Marketing authorisation holder

Regeneron Ireland Designated Activity Company (DAC)

More information

Paxlovid

INN

nirmatrelvir / ritonavir

Marketing authorisation holder

Pfizer Europe MA EEIG

More information

Pyrukynd

INN

mitapivat

Marketing authorisation holder

Agios Netherlands B.V.

More information

Tremfya

INN

guselkumab

Marketing authorisation holder

Janssen Cilag International

More information

Scemblix

INN

asciminib

Market authorisation holder

Novartis Europharm Limited

More information

Withdrawal of initial marketing authorisation application

Hydrocortisone Aguettant

INN

hydrocortisone

Market authorisation applicant

Laboratoire Aguettant

Therapeutic indication

Prevention of bronchopulmonary dysplasia in preterm infants born less than 28 weeks of gestation

More information

Public-health recommendation

Oxbryta

INN

voxelotor

Market authorisation applicant

Pfizer Europe MA EEIG

More information

Other updates

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