Zefylti (filgrastim)
- Region
- 🇪🇺 EU
- Active substance
- filgrastim
- Company
- CuraTeQ Biologics (Malta) Limited
- Status
- Authorised
- Therapeutic area
- Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Wed 12 Feb 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006400
- ATC
- L03AA02
- Official record
- www.ema.europa.eu
Indication
Zefylti is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Zefylti are similar in adults and children receiving cytotoxic chemotherapy. Zefylti is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Zefylti is indicated to increase neutrophil counts and to reduce the incidence and duration of infection related events. Zefylti is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.