This site is intended for healthcare professionals
News

FDA approves Fylnetra pegfilgrastim biosimilar in neutropenia.- Amneal Pharma

Read time: 1 mins
Published:28th May 2022

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.

Condition: Neutropenia
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.