EU green light for 13 new medicines in June

The European Medicines Agency’s (EMA) key expert group has recommended 13 medicines for approval at its June 2025 meeting. The Committee on Medicinal Products for Human Use (CHMP) has now approved 56 new drugs this year and extended the licenses of 51 existing products.

New marketing approvals were recommended for the following:

• Austedo (deutetrabenazine), for the treatment of adults with moderate-to-severe tardive dyskinesia, a disorder in which predisposed patients experience abnormal involuntary movements resulting from chronic or even episodic exposure to dopamine receptor antagonists.
• Imreplys (sargramostim) for a marketing authorisation under exceptional circumstances for the treatment of people with haematopoietic acute radiation syndrome, when the bone marrow produces fewer blood cells leading to a higher risk of infection and bleeding, following acute exposure to radiation.
• Ogsiveo (nirogacestat) for the treatment of adults with progressing desmoid tumours, a type of soft tissue tumours that form in fibrous tissue, most commonly in the abdomen, arms and legs, that do not spread to other locations.
• Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a serious disease where fat cells accumulate in the liver causing chronic inflammation.
• Zemcelpro (dorocubicel / unexpanded umbilical cord cells), a stem cell therapy to treat patients with haematological malignancies (blood cancers). This medicine provides an option for patients with blood cancer who need a blood stem cell transplant and have no suitable donor.

The committee adopted positive opinions for six biosimilar medicines:

• Mynzepli (aflibercept), and its duplicate Afiveg (aflibercept), Vgenfli (aflibercept), and its duplicate Eiyzey (aflibercept), for the treatment of age-related macular degeneration and visual impairment.
• Usymro (ustekinumab) for the treatment of plaque psoriasis, arthritis psoriatic and Crohn’s Disease.
• Vivlipeg (pegfilgrastim) to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

Two generic medicines were also recommended for approval:

• Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris (emtricitabine / rilpivirine / tenofovir alafenamide), for the treatment of adults and adolescents infected with human immunodeficiency virus type 1 (HIV-1).
• Nintedanib Viatris (nintedanib), for the treatment of idiopathic pulmonary fibrosis, other chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis associated with interstitial lung disease.

The therapeutic indications of six medicines were extended for the following products which had previously been authorised for other indications: Benlysta, Cabometyx, Darzalex, Imbruvica,  Nubeqa, and Sarclisa.

The CHMP recommended an extension of indication for one medicine intended for use outside the EU. Dapivirine Vaginal Ring 25 mg (dapivirine) is a vaginal ring originally approved in July 2020 and used to reduce the risk of women 18 years and older getting infected with human immunodeficiency virus type 1 (HIV-1) through vaginal intercourse. The new opinion extends the indication for this medicine to include its use in women from 16 years of age.

All EMA opinions are subject to formal approval by the European Commission.