Ryzneuta

Opinion

EMA has issued an opinion on this medicine

efbemalenograstim alfa

Overview

On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ryzneuta, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy. The applicant for this medicinal product is Evive Biotechnology Ireland Limited.

Ryzneuta will be available as a 20 mg solution for injection. The active substance of Ryzneuta is efbemalenograstim alfa, an immunostimulant/colony stimulating factor (ATC code: L03AA18) that belongs to the class of haematopoietic growth factors (granulocyte colony stimulating factor; G CSF) which increase the production and differentiation of mature and functionally active neutrophils from bone marrow precursor cells.

The benefit of Ryzneuta is the reduction in the duration of severe neutropenia during the first cycle of chemotherapy compared to placebo and, to a similar extent, pegfilgrastim (a pegylated G CSF). The most common side effects concern musculoskeletal pain, such as bone and back pain, arthralgia and pain in extremities.

The full indication is:

Ryzneuta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). 

Ryzneuta should be initiated and supervised by physicians experienced in oncology and/or haematology.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Ryzneuta

Reference Number: EMA/CHMP/31327/2024

Product details

• Name of medicine:
  Ryzneuta
• Active substance:
  efbemalenograstim alfa
• International non-proprietary name (INN) or common name:
  efbemalenograstim alfa
• Therapeutic area (MeSH):
  • Chemotherapy-Induced Febrile Neutropenia
  • Neutropenia
• Anatomical therapeutic chemical (ATC) code:
  L03AA18
• EMA product number:
  EMEA/H/C/005828
• Marketing authorisation applicant:
  Evive Biotechnology Ireland Limited
• Opinion adopted:
  25/01/2023