HYDERABAD: Pharma major Aurobindo Pharma on Wednesday informed the bourses that the US Food & Drug Administration (USFDA) has approved Ryzneuta (Efbemalenograstim alfa injection), a novel long-acting Granulocyte colony-stimulating factor (G-CSF) for the treatment of chemotherapy-Induced Neutropenia (CIN) in cancer patients, that it in-licenced from biopharma player Evive Biotech.
News of the US regulatory nod sent the Hyderabad-based Aurobindo Pharma‘s scrip surging to a 52-week high of Rs 1058.20 on the Bombay Stock Exchange (BSE) before closing 2.77% up at Rs 1055.15 on Wednesday.
Ryzneuta is the first non-pegylated G-CSF approved by both USFDA and China’s National Medical Products Administration (NMPA), for the treatment of CIN. The drug was in-licenced by Aurobindo’s step-down subsidiary Acrotech Biopharma last year.
The New Jersey based Acrotech is a wholly owned subsidiary of Aurobindo Pharma USA Inc, which in turn is a wholly owned arm of Hyderabad-based Aurobindo Pharma.
“Acrotech is preparing to commercialize Ryzneuta in the near future. We believe it 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 Acrotech Biopharma president Dr Ashish Anvekar.
Simon Li, MD, CEO & CMO of Evive said his company would work with Acrotech to bring the novel treatment to more cancer patients with CIN in the US.
The approval was based on results of two pivotal Phase 3 studies – Study GC-627-04 [NCT02872103] and Study GC-627-05 [NCT03252431] — completed in the United States and Europe, Aurobindo Pharma said in a regulatory filing to the bourses on Wednesday.
“Ryzneuta is a new treatment option that has demonstrated its efficacy and safety building on the comprehensive global development programme 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.
Ryzneuta, which can stimulate the proliferation, differentiation, and release of neutrophil precursors, is a novel dimeric G-CSF long-acting fusion protein without PEGylation (or Tween-80) that helps enhance the immune function of cancer patients and prevent the side effects of neutropenia caused by chemotherapy, it added.
“Due to its unique molecular structure, RyzneutaTM may possess stronger G-CSF receptor activation properties and avoid potential problems such as allergic reactions caused by PEG or Tween-80,” it explained.
Neutropenia, which is a common side effect of chemotherapy that 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, increases the risk of adverse reactions such as infection and fever in cancer patients during chemotherapy.
Ryzneuta was approved and launched in China in May this year and the facility manufacturing producing Ryzneuta has successfully passed the on-site GMP inspections conducted by ANVISA and EMA, the company said, adding that in the near future Ryzneuta is expected to receive more regulatory approvals, emerging as a much-needed effective first-line treatment and alternative therapy.
Evive Biotech, a global biopharmaceutical company focused on developing novel biologic therapies, is a subsidiary of Chinese player Yifan Pharmaceutical Co Ltd.
News of the US regulatory nod sent the Hyderabad-based Aurobindo Pharma‘s scrip surging to a 52-week high of Rs 1058.20 on the Bombay Stock Exchange (BSE) before closing 2.77% up at Rs 1055.15 on Wednesday.
Ryzneuta is the first non-pegylated G-CSF approved by both USFDA and China’s National Medical Products Administration (NMPA), for the treatment of CIN. The drug was in-licenced by Aurobindo’s step-down subsidiary Acrotech Biopharma last year.
The New Jersey based Acrotech is a wholly owned subsidiary of Aurobindo Pharma USA Inc, which in turn is a wholly owned arm of Hyderabad-based Aurobindo Pharma.
“Acrotech is preparing to commercialize Ryzneuta in the near future. We believe it 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 Acrotech Biopharma president Dr Ashish Anvekar.
Simon Li, MD, CEO & CMO of Evive said his company would work with Acrotech to bring the novel treatment to more cancer patients with CIN in the US.
The approval was based on results of two pivotal Phase 3 studies – Study GC-627-04 [NCT02872103] and Study GC-627-05 [NCT03252431] — completed in the United States and Europe, Aurobindo Pharma said in a regulatory filing to the bourses on Wednesday.
“Ryzneuta is a new treatment option that has demonstrated its efficacy and safety building on the comprehensive global development programme 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.
Ryzneuta, which can stimulate the proliferation, differentiation, and release of neutrophil precursors, is a novel dimeric G-CSF long-acting fusion protein without PEGylation (or Tween-80) that helps enhance the immune function of cancer patients and prevent the side effects of neutropenia caused by chemotherapy, it added.
“Due to its unique molecular structure, RyzneutaTM may possess stronger G-CSF receptor activation properties and avoid potential problems such as allergic reactions caused by PEG or Tween-80,” it explained.
Neutropenia, which is a common side effect of chemotherapy that 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, increases the risk of adverse reactions such as infection and fever in cancer patients during chemotherapy.
Ryzneuta was approved and launched in China in May this year and the facility manufacturing producing Ryzneuta has successfully passed the on-site GMP inspections conducted by ANVISA and EMA, the company said, adding that in the near future Ryzneuta is expected to receive more regulatory approvals, emerging as a much-needed effective first-line treatment and alternative therapy.
Evive Biotech, a global biopharmaceutical company focused on developing novel biologic therapies, is a subsidiary of Chinese player Yifan Pharmaceutical Co Ltd.
