Ryzneuta for chemotherapy-induced neutropenia receives USFDA approval

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New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA, Acrotech Biopharma, and Evive Biotech, a biopharmaceutical company and subsidiary of Yifan Pharmaceutical and Acrotech Biopharma, on Wednesday announced that on November 16, 2023, the U.S. Food and Drug Administration (FDA) approved Ryzneuta (Efbemalenograstim alfa) for the treatment of chemotherapy-induced neutropenia (CIN) in adult patients with non-myeloid malignancies.


Ryzneuta helps to stimulate the production of neutrophils, a type of white blood cell that fights infection. Neutropenia is a common side effect of chemotherapy and can increase the risk of infection in cancer patients.


Ryzneuta is the first non-pegylated granulocyte colony-stimulating factor to receive approval from both the US Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA).


Commenting on this, Simon Li, M.D., Ph.D., CEO & CMO of Evive stated, “Ryzneuta is the first innovative biologics independently developed by Evive Biotech, and this approval proves that the Evive R&D team has the capability to independently carry out the global development of innovative biologics. We look forward to working with Acrotech to bring this novel treatment to more cancer patients with CIN in the US.”


Echoing the sentiment, John Glaspy, Principal Investigator of the Ryzneuta global clinical trial program stated, “Ryzneuta is a new treatment option that has demonstrated its efficacy and safety building on the comprehensive global development program of Ryzneuta™, which includes 12 clinical trials and has enrolled over 1,200 subjects to date in multiple territories including the US, EU, and China.”


Acrotech Biopharma is preparing to commercialise Ryzneuta in the United States in the near future. The company believes that Ryzneuta will offer patients a compelling and accessible treatment option for CIN.


Ashish Anvekar, President of Acrotech Biopharma stated, “Acrotech is very excited about the approval of Ryzneuta and is preparing to commercialise the product in the near future. We will leverage our strong and well-established commercial footprint to promote this unique treatment to key stakeholders.”