Ten new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its November 2025 meeting.

The committee recommended granting a marketing authorisation for Dawnzera (donidalorsen), for the routine prevention of recurrent attacks of hereditary angioedema (swelling) in adults and adolescents aged 12 years and older. Patients with hereditary angioedema have attacks of rapid swelling such as in the face, throat, arms and legs, or around the gut.

The CHMP recommended granting a marketing authorisation for GalenVita (germanium (68Ge) chloride / gallium (68Ga) chloride), a radionuclide generator. GalenVita is used to produce gallium (68Ga) chloride solution, that is used to label carrier molecules used for positron emission tomography (PET) diagnostic imaging of different types of tumours.

Inluriyo (imlunestrant) received a positive opinion from the CHMP for the treatment of adults with locally advanced or metastatic breast cancer with a specific mutation in the gene ESR1.

A positive opinion was adopted for Teizeild (teplizumab), a first-in-class treatment to delay the onset of stage 3 type 1 diabetes in adults and in children from eight years of age with stage 2 type 1 diabetes. 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.

The committee recommended granting a marketing authorisation for Vacpertagen (acellular pertussis vaccine), a vaccine used to prevent pertussis, often called whooping cough, a highly infectious disease that can occur at any age.

The CHMP adopted a positive opinion for Waskyra (etuvetidigene autotemcel),the first gene therapy to treat Wiskott-Aldrich syndrome, a rare, inherited disease, seen almost exclusively in males, that affects blood cells and cells of the immune system. See more details in the news announcement in the grid below.

Enzalutamide Accordpharma (enzalutamide), received a positive opinion from the CHMP for the treatment of prostate cancer. This medicine was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product and in part on new data.

The committee adopted positive opinions for two biosimilar medicines:

Ondibta (insulin glargine), for the treatment of diabetes mellitus.
Osqay (denosumab), for the treatment of osteoporosis and bone loss.

A generic medicine, Teduglutide Viatris (teduglutide), received a positive opinion for the treatment of short bowel syndrome, a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.

Recommendations on extensions of therapeutic indication for four medicines

The committee recommended extensions of indication for four medicines that are already authorised in the EU: Koselugo, Minjuvi, Veyvondi and Xerava.

Withdrawal of applications

Three applications for initial marketing authorisation were withdrawn:

Insulin Aspart Injection (insulin aspart), intended for the treatment of diabetes in adults and children aged one year and above.
Nurzigma (pridopidine), for the treatment of adults with Huntington’s disease, an inherited condition that worsens over time and causes brain cells to die.
Ohtuvayre (ensifentrine), for maintenance treatment for adults with symptoms of chronic obstructive pulmonary disease, a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing.

Question-and-answer documents on the withdrawals of these medicines are available in the grid below.

Outcome of re-examination

Following a re-examination at the request of the applicant for Aqneursa (levacetylleucine), a medicine for the treatment of Niemann-Pick type C, a rare, progressive, fatal genetic disorder, the committee confirmed its initial recommendation not to consider levacetylleucine as a new active substance.

For more information, see the grid below.

Start of re-examination

The marketing authorisation holder for Rezurock (belumosudil) has requested a re-examination of the negative opinion adopted during the committee’s October 2025 meeting.

Upon receipt of the grounds of this request, the CHMP will re-examine its opinion and issue a final recommendation.

Agenda and minutes

The agenda of the November 2025 CHMP meeting is published on EMA’s website. Minutes of the meeting will be published in the coming weeks.

CHMP statistics

Key figures from the November 2025 CHMP meeting are represented in the graphic below.