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Galectin Therapeutics has submitted a Fast Track application to the FDA to help expedite its clinical development program.
Galectin Therapeutics has submitted a Fast Track application to the FDA to help expedite its clinical development program of GR-MD-02 in the treatment of non-alcoholic steatohepatitis (NASH, or fatty liver disease) with advanced fibrosis.
GR-MD-02 has shown robust treatment effects in reversing fibrosis and cirrhosis in pre-clinical studies and a phase 1 clinical trial in patients with NASH with advanced fibrosis is currently enrolling.
A drug that receives Fast Track designation is eligible for regulatory benefits from the FDA that can lead to earlier drug approval and access by patients, including more frequent meetings and interactions with the agency during development to ensure appropriate clinical design and data collection. Drugs receiving Fast Track status are also eligible for Rolling Review, Priority Review, and Accelerated Approval pathways.