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:
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.
The committee recommended extensions of indication for four medicines that are already authorised in the EU: Koselugo, Minjuvi, Veyvondi and Xerava.
Three applications for initial marketing authorisation were withdrawn:
Question-and-answer documents on the withdrawals of these medicines are available in the grid below.
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.
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.
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.
Key figures from the November 2025 CHMP meeting are represented in the graphic below.
November 2025 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
10 positive opinions on new medicines: 4 new non-orphan medicine, 2 orphan medicine, 2 biosimilars, and 2 generic, hybrid or informed consent medicine. Total in 2025: 97
0 negative opinions on new medicines. Total in 2025: 6
4 positive opinions on extensions of therapeutic indication. Total in 2025: 77
3 withdrawn applications for new medicines. Total in 2025: 21
donidalorsen
Otsuka Pharmaceutical Netherlands B.V.
For routine prevention of recurrent attacks of hereditary angioedema (HAE).
This medicine was designated an orphan medicine.
Germanium (68Ge) chloride / Gallium (68Ga) chloride
Curium Romania S.R.L.
Indicated for in vitro radiolabelling of specific carrier molecules to be used for positron emission tomography (PET) imaging.
imlunestrant
Eli Lilly Nederland B.V.
Monotherapy for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2).
In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
teplizumab
Sanofi Winthrop Industrie
To delay the onset of Stage 3 type 1 diabetes (T1D).
pertussis vaccine (recombinant, acellular, component, adsorbed)
BioNet Europe
Indicated as booster immunization against pertussis of individuals 12 years of age and older and passive protection against pertussis in early infancy following maternal immunization during pregnancy.
Autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-Aldrich syndrome protein
Fondazione Telethon Ets
Treatment of patients with Wiskott-Aldrich Syndrome (WAS).
This medicine was designated an orphan medicine.
enzalutamide
Accord Healthcare
Treatment of prostate cancer.
insulin glargine
Gan & Lee Pharmaceuticals Europe GmbH
Treatment of diabetes mellitus.
denosumab
Theramex Ireland Limited
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients.
teduglutide
Viatris Limited
Treatment of Short Bowel Syndrome.
selumetinib
AstraZeneca AB
This medicine was designated an orphan medicine.
tafasitamab
Incyte Biosciences Distribution B.V.
vonicog alfa
Baxalta Innovations GmbH
eravacycline
PAION Pharma GmbH
tasimelteon
Vanda Pharmaceuticals Netherlands B.V.
levacetylleucine
Intrabio Ireland Limited
Chronic treatment of Niemann-Pick Type C (NPC) in adults and children from birth.
This medicine was designated an orphan medicine.
belumosudil
Sanofi Winthrop Industrie
Treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy
This medicine was designated an orphan medicine.
insulin aspart
Masuu Pharma Europe Limited
Treatment of diabetes mellitus.
pridopidine
Prilenia Therapeutics B.V.
Treatment of adults with Huntington’s disease
ensifentrine
Verona Pharma Ireland Limited
Maintenance treatment in symptomatic adult patients with chronic obstructive pulmonary disease (COPD).