Aurobindo Pharma USA arm, Evive Biotech bags USFDA nod for Ryzneuta for Chemotherapy-Induced Neutropenia
Ryzneuta is a novel long-acting Granulocyte colonystimulating factor (G-CSF), which can stimulate the proliferation, differentiation, and release of neutrophil precursors.
New Jersey: Evive Biotech, a global biopharmaceutical company developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., and Acrotech Biopharma, a New Jersey-based and wholly-owned subsidiary of Aurobindo Pharma USA Inc., today announced that the U.S. 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 pivotal Phase 3 Study GC-627-04 [NCT02872103] and Study GC-627-05 [NCT03252431] completed in the United States 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, randomized, 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 characterized 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.
“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, including preclinical research, regulatory affairs, clinical research, manufacturing following international standard, as well as commercialization,” said Simon Li, M.D., Ph.D., CEO & CMO of Evive. “We look forward to working with Acrotech to bring this novel treatment to more cancer patients with CIN in the US.”
“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,” said Dr. John Glaspy, Principal Investigator of the Ryzneuta global clinical trial program and professor of medicine at the Jonsson Comprehensive Cancer Center of the University of California, Los Angeles School of Medicine, “and I am proud of the achievement made by Evive team and the devotion of the patients and research teams involved in these studies. We hope that this promising therapy will benefit more CIN patients.”
“Acrotech is very excited on the approval of Ryzneuta and is preparing to commercialize 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.” said Dr. Ashish Anvekar, President of Acrotech Biopharma.
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.
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