Ceescamel · CC BY-SA 4.0 · Wikimedia Commons · Source · License
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) announced on November 13 that it had recommended seven new medicines for marketing authorization and approved 11 extensions of therapeutic indications during its regular meeting held from November 9 to 12, 2026. The meeting also addressed positive opinions for medicines intended for use outside the EU, confirmed refusals of authorization following re-examination, two withdrawals of marketing authorization applications, and the adoption of a Direct Healthcare Professional Communication (DHPC) regarding the efficacy of contraceptives in patients using Mounjaro.
CHMP Recommends 7 New Medicines for Hypertension, Lung Cancer, and Diabetes
The CHMP recommended seven medicines for marketing authorization, including three new medicines, two biosimilars, and two generics. Key new medicines include Baxfendy (baxdrostat) for the treatment of adult hypertension not adequately controlled by existing therapies, Aumseqa (aumolertinib) for adult non-small cell lung cancer (NSCLC), and Zybrivo (sintilimab) for adult non-squamous NSCLC.
In the field of diabetes treatment, Garzulys and Donrafylix, insulin aspart biosimilar products for pediatric patients (1 year and older), adolescents, and adults, received positive opinions. Regarding generics, the committee recommended Fondaparinux sodium Evumed for the prevention of venous thromboembolism (VTE) and the treatment of deep vein thrombosis (DVT), pulmonary embolism, unstable angina, and myocardial infarction in adults, as well as Ruxolitinib Krka for the treatment of myelofibrosis (MF), polycythemia vera (PV), and graft-versus-host disease (GvHD) in adults and children.
11 Extensions of Indications Approved, Including Systemic Lupus Erythematosus and Cushing’s Syndrome
The CHMP recommended extending the therapeutic indications for 11 previously authorized medicines. Gazyvaro (obinutuzumab) was recommended for expansion to include the treatment of adult patients with moderate to severe active systemic lupus erythematosus (SLE) whose disease is not adequately controlled by standard therapies. Gazyvaro helps reduce disease activity while lowering corticosteroid dosage and the associated risks of side effects.
Isturisa (osilodrostat), used for the treatment of endogenous Cushing’s syndrome—a rare disorder where the adrenal glands produce excess cortisol—received a positive opinion to extend its use to pediatric patients aged 6 years and older. Furthermore, extensions were approved for nine other medicines: Bexsero, Cosentyx, Dovato, Enflonsia, Steglatro, Sunlenca, Talzenna, Tivicay, and Welireg.
Approval of New Dosage for Dapivirine Vaginal Ring to Support Public Health Outside the EU
Through the ‘EU-Medicines for all (EU-M4All)’ procedure, which supports public health and strengthens regulatory capacity outside the EU, the EMA issued a positive opinion for a new 100mg high-dose formulation of the Dapivirine Vaginal Ring. Used to reduce the risk of HIV-1 infection in women aged 16 and older, the higher dose extends the ring’s replacement cycle from one month to three months.
This assessment involved collaboration with World Health Organization (WHO) experts and national regulatory authorities from Kenya, South Africa, and Zambia.
Two Refusals Confirmed After Re-examination and Two Applications Withdrawn
Following a re-examination of initial opinions, the CHMP confirmed the refusal of marketing authorization for two medicines. These include KemSu (sufentanil/ketamine), proposed for acute pain in children and adolescents aged 1 to 18, and Meplyffa (arimoclomol citrate) for Niemann-Pick disease type C, a rare genetic neurodegenerative condition, in combination with miglustat in patients aged 2 and older.
Additionally, two companies voluntarily withdrew their marketing authorization applications. These include Amlypave (anselamimab) for the treatment of AL amyloidosis, which affects the heart in adult patients, and Qezzaqar (catequetinib), which was being developed for soft tissue sarcomas such as leiomyosarcoma and synovial sarcoma.
Risk of Reduced Oral Contraceptive Efficacy with Mounjaro and Recommended Response
The CHMP has adopted a Direct Healthcare Professional Communication (DHPC) regarding the impact of Mounjaro (tirzepatide), used for type 2 diabetes and weight management, on the pharmacokinetics and efficacy of oral contraceptives. It was noted that information is currently limited regarding the effect of tirzepatide on the pharmacokinetics and efficacy of oral contraceptives in women with obesity, overweight, or type 2 diabetes.
Consequently, it is recommended that women of childbearing potential starting or increasing the dosage of Mounjaro use an additional barrier method of contraception or switch to a non-oral contraceptive method for 4 weeks after initiating treatment and for 4 weeks after each dose increase. Following the European Commission’s decision, the marketing authorization holder will distribute this information to healthcare professionals and publish it on the EMA website and via national registries in EU member states.