Imreplys

Opinion

EMA has issued an opinion on this medicine

sargramostim

Overview

On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances¹ for the medicinal product Imreplys, intended for the treatment of people with haematopoietic acute radiation syndrome (H-ARS) following acute exposure to myelosuppressive doses of radiation. The applicant for this medicinal product is Partner Therapeutics Ltd.

Imreplys will be available as a 250 μg powder for solution for injection. The active substance of Imreplys, sargramostim, is a colony-stimulating factor (ATC code: L03AA09). Sargramostim is a granulocyte-macrophage colony-stimulating factor which induces the bone marrow to produce certain types of white blood cells, such as granulocytes, macrophages and monocytes, as well as red blood cells and platelets.

The benefits of Imreplys are increased 60-day survival rates in Rhesus monkeys who received H-ARS-inducing total body irradiation, compared with placebo, as shown in 3 randomised, blinded, placebo-controlled studies. All studies have also shown faster recovery of absolute neutrophil counts and platelets, reduced infection rates and fewer signs of sepsis. The most common side effects with Imreplys include fever, diarrhoea, vomiting, skin reactions, rash, asthenia, metabolic laboratory abnormalities, malaise, high glucose, abdominal pain, weight loss, low albumin, pruritus, gastrointestinal haemorrhage, chills, pharyngitis, bone pain, chest pain, hypomagnesaemia, haematemesis, arthralgia, anxiety, and eye haemorrhage.

The full indication is:

Imreplys is 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].

Imreplys should be used in accordance with official radiological/nuclear emergency recommendations.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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¹ In exceptional circumstances, an authorisation may be granted subject to certain specific obligations, to be reviewed annually. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicinal product, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

CHMP summary of positive opinion for Imreplys

AdoptedReference Number: EMA/CHMP/82619/2025

Product details

• Name of medicine:
  Imreplys
• Active substance:
  sargramostim
• International non-proprietary name (INN) or common name:
  sargramostim
• Therapeutic area (MeSH):
  Acute Radiation Syndrome
• Anatomical therapeutic chemical (ATC) code:
  L03AA09
• EMA product number:
  EMEA/H/C/006411
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation applicant:
  Partner Therapeutics Limited
• Opinion adopted:
  19/06/2025
• Opinion status:
  Positive