Posted by Michael Wonder on 21 Jun 2025
European Medicines Agency CHMP recommends EU approval of Partner Therapeutics Imreplys (sargramostim, rhu GM-CSF) to treat exposure to myelosuppressive doses of radiation (Haematopoietic Sub-syndrome of Acute Radiation Syndrome)
20 June 2025 - Partner Therapeutics today announced that the CHMP of the EMA has recommended approval of PTx's marketing authorisation application for Imreplys (sargramostim, rhu GM-CSF), the same formulation that was approved by the US FDA under the brand name Leukine in 2018.
Imreplys would be indicated for treatment of patients of all ages acutely exposed to myelosuppressive doses of radiation with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS).
