June 2025 batch of EMA/CHMP recommendations

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its June 2025 meeting.

The committee recommended granting a marketing authorization for Israeli company Teva Pharmaceutical Industries’ (NYSE: TEVA) 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), from USA-based Partner Therapeutics, received a positive opinion from the CHMP for a marketing authorization under exceptional circumstances for the treatment of people with hematopoietic 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.