FDA approves Fylnetra pegfilgrastim biosimilar in neutropenia.- Amneal Pharma
Amneal Pharmaceuticals announced that the FDA has approved the Company’s Biologics License Application for Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Neulasta. Fylnetra was developed in collaboration with Kashiv Biosciences, LLC, located in Chicago, Illinois.
It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy. Most common adverse reactions (at least 5% difference in incidence compared to placebo) are bone pain and pain in extremity.
Fylnetra is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use: the drug is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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