Evive Biotech (Evive), a subsidiary of Yifan Pharmaceutical Co, and Acrotech Biopharma (Acrotech), a wholly-owned subsidiary of Aurobindo Pharma USA, announced that the US Food and Drug Administration (FDA) approved Ryzneuta (Efbemalenograstim alfa) indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
The approval was based on results of the two Phase 3 trials, Study GC-627-04 [NCT02872103] and Study GC-627-05 [NCT03252431] completed in the US and Europe. Ryzneuta is a novel long-acting Granulocyte colonystimulating factor (G-CSF), which can stimulate the proliferation, differentiation, and release of neutrophil precursors. It helps to enhance the immune function of cancer patients and prevent the side effects of neutropenia caused by chemotherapy.
Study GC-627-05, is a multi-center, randomised, multi-dose, active-controlled study comparing the efficacy and safety of Ryzneuta and Neulasta (Pegfilgrastim). The trial met its primary and secondary endpoints, of efficacy and safety.
Neutropenia is a common side effect of chemotherapy and is characterised by persistently low levels of neutrophils (a type of white blood cell with infection-fighting functions) due to the use of chemotherapy and other types of anti-cancer drugs, which increases the risk of adverse reactions such as infection and fever in cancer patients during chemotherapy. Ryzneuta is a novel dimeric G-CSF long-acting fusion protein without PEGylation or Tween-80. Due to its unique molecular structure, Ryzneuta may possess stronger GCSF receptor activation properties and avoid the potential problem (such as allergic reactions) caused by PEG or Tween-80.
A press statement informed, “In May this year, Ryzneuta was approved and launched in China. In addition, the facility producing Ryzneuta has successfully passed the on-site GMP inspections conducted by ANVISA and EMA. In the near future, Ryzneuta is expected to receive more regulatory approvals, which will enable Ryzneuta to help and provide worldwide cancer patients a much-needed effective first-line treatment and alternative therapy.”