Efbemalenograstim alfa, sold under the brand name Ryzneuta, is a medication used to decrease the incidence of infection in chemotherapy-induced neutropenia.[1] It is a leukocyte growth factor.[1] It is given by subcutaneous injection.[1]
| Clinical data | |
|---|---|
| Trade names | Ryzneuta |
| Other names | F-627, efbemalenograstim alfa-vuxw, benegrastim |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624001 |
| License data | |
| Routes of administration | Subcutaneous |
| Drug class | Immunological agent |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| UNII | |
| KEGG | |
Efbemalenograstim alfa is an immunostimulant/colony stimulating factor that belongs to the class of hematopoietic 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.[2]
It was approved for medical use in China in May 2023,[4] in the United States in November 2023,[1][5] and in the European Union in March 2024.[2][3]
Medical uses edit
Efbemalenograstim alfa is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.[6]
Society and culture edit
Legal status edit
It was approved for medical use in China in May 2023,[4] and in the United States in November 2023.[1]
In January 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ryzneuta, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.[2] The applicant for this medicinal product is Evive Biotechnology Ireland Limited.[2] Efbemalenograstim alfa was approved for medical use in the European Union in March 2024.[2][3]
References edit
- ^ a b c d e f "Ryzneuta- efbemalenograstim alfa-vuxw injection". DailyMed. 23 November 2023. Archived from the original on 12 December 2023. Retrieved 12 December 2023.
- ^ a b c d e f "Ryzneuta EPAR". European Medicines Agency (EMA). 25 January 2024. Retrieved 3 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c "Ryzneuta Product information". Union Register of medicinal products. 22 March 2024. Retrieved 1 April 2024.
- ^ a b c Blair HA (August 2023). "Efbemalenograstim Alfa: First Approval". Drugs. 83 (12): 1125–1130. doi:10.1007/s40265-023-01911-7. PMID 37368138. S2CID 259260831. Archived from the original on 20 November 2023. Retrieved 18 November 2023.
- ^ "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 17 November 2023. Archived from the original on 21 January 2023. Retrieved 20 November 2023.
- ^ Yanoff L (16 November 2023). "Ryzneuta (efbemalenograstim alfa-vuxw) injection" (PDF). Biologics license application (BLA) approval letter. Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. Archived from the original (PDF) on 17 November 2023.
This article incorporates text from this source, which is in the public domain.
External links edit
- "Efbemalenograstim alfa (Code C102854)". NCI Thesaurus. 25 September 2023.
- Clinical trial number NCT02872103 for "Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy" at ClinicalTrials.gov
- Clinical trial number NCT03252431 for "Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy" at ClinicalTrials.gov
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