Aurobindo Pharma subsidiary receives USFDA approval for Ryzeneuta

Global pharmaceutical company Evive Biotech and Acrotech Biopharma received the US Food and Drug Administration (FDA)'s approval for Ryzeneuta (Efbemalenograstim alfa). Evive Biotech is a subsidiary of a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA Inc.

The Ryzeneuta is used 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 company informed in a regulatory filing with the BSE.

Ryzneuta is a novel long-acting Granulocyte colony-stimulating 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, the company said.

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Neutropenia is a common side effect of chemotherapy and is characterised by persistently low levels of neutrophils 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.

Talking about the FDA approval, President of Acrotech Biopharma, Ashish Anvekar said, "Acrotech is very excited about the approval of Ryzneuta™ and is preparing to commercialise the product in the near future. We believe Ryzneuta™ will offer patients suffering from CIN a very compelling and accessible treatment option. We will leverage our strong and well-established commercial footprint to promote this unique treatment to key stakeholders."