Hyderabad: Pharma Head Aurobindo Pharma Stock exchanges were informed on Wednesday that the US Food and Drug Administration (USFDA) has approved RizeNuta (fbemelanograstim alfa), a long-acting granulocyte colony-stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia (CIN). Injection) has been approved. In cancer patients, it is licensed from the biopharmaceutical company Iviva Biotech.
news of US regulatory approval Sent Aurobindo Pharma based in HyderabadOn Wednesday, its shares hit a 52-week high of Rs 1058.20 before closing 2.77% higher at Rs 1055.15 on the Bombay Stock Exchange (BSE).
Ryzneuta is the first non-PEGylated G-CSF approved by both the USFDA and the National Medical Products Administration (NMPA) of China for the treatment of CIN. The drug was licensed last year by Aurobindo’s subsidiary Acrotech Biopharma.
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 RiseNuTa in the near future. We believe this will provide a very attractive and accessible treatment option to patients suffering from CIN. We will leverage our strong and well-established commercial footprint to promote this unique treatment to key stakeholders,” said Dr Ashish Anvekar, Chairman, Acrotech Biopharma.
Simon Lee, MD, CEO and CMO of Iviway, said his company will work with Acrotech to bring the new treatment to more cancer patients with CIN in the US.
Aurobindo Pharma said in a regulatory filing that the approval was based on the 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. Stock market on Wednesday.
“RiseNuta is a new treatment option that has demonstrated its efficacy and safety building on RizeNuta’s extensive global development program, which includes 12 clinical trials and more than 1,200 patients to date in multiple regions, including the US, EU and China More subjects have been nominated.” said Dr. John Glaspie, principal investigator of the RESNUTA global clinical trial program and professor of medicine at the Johnson Comprehensive Cancer Center at the University of California, Los Angeles School of Medicine.
Rhizneuta, which can stimulate the proliferation, differentiation and release of neutrophil precursors, is a new dimeric G-CSF long-acting fusion protein without PEGylation (or Twin-80) that can improve the immune function of cancer patients. Helps in increasing and preventing side effects. due to neutropenia ChemotherapyThis was added.
“Due to its unique molecular structure, RyzneutaTM may have stronger G-CSF receptor activation properties and avoid potential problems such as allergic reactions caused by PEG or Tween-80,” it explained.
Neutropenia, a common side effect of chemotherapy in which levels of neutrophils (a type of white blood cell with infection-fighting functions) become persistently low due to the use of chemotherapy and other types of anticancer drugs, increases the risk. Is. 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 producing Ryzneuta has successfully passed on-site GMP inspections conducted by ANVISA and EMA, the company said, adding that Ryzneuta will be developed further in the near future. More regulatory approvals are expected to be received. , is emerging as a much-needed effective first-line treatment and alternative medicine.
IVIVE Biotech, a global biopharmaceutical company focused on developing novel biologic therapies, is a subsidiary of Chinese company Yifan Pharmaceutical Co., Ltd.
news of US regulatory approval Sent Aurobindo Pharma based in HyderabadOn Wednesday, its shares hit a 52-week high of Rs 1058.20 before closing 2.77% higher at Rs 1055.15 on the Bombay Stock Exchange (BSE).
Ryzneuta is the first non-PEGylated G-CSF approved by both the USFDA and the National Medical Products Administration (NMPA) of China for the treatment of CIN. The drug was licensed last year by Aurobindo’s subsidiary Acrotech Biopharma.
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 RiseNuTa in the near future. We believe this will provide a very attractive and accessible treatment option to patients suffering from CIN. We will leverage our strong and well-established commercial footprint to promote this unique treatment to key stakeholders,” said Dr Ashish Anvekar, Chairman, Acrotech Biopharma.
Simon Lee, MD, CEO and CMO of Iviway, said his company will work with Acrotech to bring the new treatment to more cancer patients with CIN in the US.
Aurobindo Pharma said in a regulatory filing that the approval was based on the 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. Stock market on Wednesday.
“RiseNuta is a new treatment option that has demonstrated its efficacy and safety building on RizeNuta’s extensive global development program, which includes 12 clinical trials and more than 1,200 patients to date in multiple regions, including the US, EU and China More subjects have been nominated.” said Dr. John Glaspie, principal investigator of the RESNUTA global clinical trial program and professor of medicine at the Johnson Comprehensive Cancer Center at the University of California, Los Angeles School of Medicine.
Rhizneuta, which can stimulate the proliferation, differentiation and release of neutrophil precursors, is a new dimeric G-CSF long-acting fusion protein without PEGylation (or Twin-80) that can improve the immune function of cancer patients. Helps in increasing and preventing side effects. due to neutropenia ChemotherapyThis was added.
“Due to its unique molecular structure, RyzneutaTM may have stronger G-CSF receptor activation properties and avoid potential problems such as allergic reactions caused by PEG or Tween-80,” it explained.
Neutropenia, a common side effect of chemotherapy in which levels of neutrophils (a type of white blood cell with infection-fighting functions) become persistently low due to the use of chemotherapy and other types of anticancer drugs, increases the risk. Is. 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 producing Ryzneuta has successfully passed on-site GMP inspections conducted by ANVISA and EMA, the company said, adding that Ryzneuta will be developed further in the near future. More regulatory approvals are expected to be received. , is emerging as a much-needed effective first-line treatment and alternative medicine.
IVIVE Biotech, a global biopharmaceutical company focused on developing novel biologic therapies, is a subsidiary of Chinese company Yifan Pharmaceutical Co., Ltd.
(TagstoTranslate)Business News(T)USFDA approval(T)US regulatory approval(T)Hyderabad-based Aurobindo Pharma(T)Chemotherapy(T)Aurobindo Pharma
