FibroGen’s FG-3019, a human monoclonal antibody for the treatment of idiopathic Pulmonary Fibrosis (IPF) received approval from Food and Drug Administration (FDA) as Orphan drug. FG-3019 antagonizes connective tissue growth factor (CTGF), a key factor in the pathogenesis of fibrosis.
FibroGen’s CEO, Thomas Neff says, the FDA’s approval for FG-3019 as Orphan drug is a milestone in development of FG-3019 for treatment of IPF and FibroGen is committed for further research in FG-3019 to improve safety and efficacy in IPF treatment. The Phase-II clinical trial study results reported increased plasma half-life of FG-3019 that can significantly prevent decline in lung functions and increases lung capacity, in some patients.
In Phase-I clinical trial studies, FG-3019 was studied involving more than 200 volunteers with IPF and Phase-II clinical trials are underway in IPF patients and volunteers with other diseases that lead to fibrotic changes such as Hepatitis B. This study is aimed to prevent Hepatitis B induced liver fibrosis as well as hepatocellular carcinoma. Similar studies are conducted in drug resistant pancreatic tumors across various geographical locations. In all phases of clinical trials, the FG-3019 was well tolerated by the study participants without any serious adverse events.
FDA grants Orphan drug status to drugs and/or biologics used in treatment of rare disease/disorders. The advantage of this status is that the sponsor will receive fee waiving for prescription drug use, deduction of tax up to fifty percentages of clinical trial expenses and exclusive marketing license in US for seven years, after approval.
FibroGen is committed to developing drugs and biologics for treatment of fibrotic diseases and disorders and conducting basic and clinical research on CTGF and associated molecular pathways of tissue fibrosis for more than ten years.
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