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13 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its June 2025 meeting.
The committee recommended granting a marketing authorisation for 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) received a positive opinion from the CHMP 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.
A positive opinion was adopted for 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.
The committee recommended granting a conditional marketing authorisation for 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. Currently, there is no authorised treatment for metabolic dysfunction-associated steatohepatitis in the European Union (EU). See more details in the news announcement in the grid below.
The CHMP recommended granting a conditional marketing authorisation for 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. 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 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 received a positive opinion:
- 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.
Recommendations on extensions of therapeutic indication for six medicines
The committee recommended extensions of indication for six medicines that are already authorised in the EU: Benlysta, Cabometyx, Darzalex*, Imbruvica, Nubeqa, and Sarclisa.
Recommendations on extensions of therapeutic indication for one medicine intended for use outside the EU
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 CHMP’s opinion extends the indication for this medicine to include its use in women from 16 years of age.
This medicine was submitted under a regulatory procedure known as EU-Medicines for all (EU-M4All) that enables EMA to support global regulatory capacity building and contribute to the protection and promotion of public health beyond the EU.
Start of re-examination of recommendations
The marketing authorisation holder for Atropine sulfate FGK (atropine), a medicine intended to slow myopia progression in children aged 6 to 10 years with spherical equivalent refraction (SER) in the range of -0.50 to ‑6.00 diopter (D), has requested a re-examination of the negative opinion adopted during the committee’s May 2025 meeting.
The CHMP started a re-examination of its March 2025 recommendation not to grant a marketing authorisation for Kisunla (donanemab), a medicine intended for the treatment of early Alzheimer’s disease. The re-examination started on 2 June following a request from the applicant.
Upon receipt of the grounds of these requests, the CHMP will re-examine its opinions and issue final recommendations.
Start of referral
The CHMP started a review of medicines containing sodium oxybate used in people with alcohol dependency to treat alcohol withdrawal syndrome and to support long term abstinence. The review has been initiated at the request of the French Medicines Agency under Article 31 of Directive 2001/83/EC.
For more information, see the public health communication in the grid below.
Agenda and minutes
The agenda of the June 2025 CHMP meeting is published on EMA’s website. Minutes of the meeting will be published in the coming weeks.
*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.
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