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FDA Grants Fast Track Designation for NAFLD and NASH Combination Therapy
Pre-clinical studies have shown the potential of NuSirt technology to target the three pathophysiological aspects of NASH: steatosis, inflammation and fibrosis
NuSirt Biopharma Receives FDA Fast Track Designation for Non-Alcoholic Fatty Liver Disease Treatment
December 31, 2015 | Business Wire
NASHVILLE, Tenn.–(BUSINESS WIRE)–NuSirt Biopharma today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its development program focused on non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). NuSirt also announced the start of enrollment for its Phase 2A clinical trial targeting this disease at nine U.S. research sites.
“NAFLD and NASH represent serious unmet medical needs for which there are no approved therapies,” said Joseph C. Cook, Jr., president and executive chairman of the board of NuSirt Biopharma. “It is estimated that 75-100 million people in the U.S. have NAFLD, and 10-20 million have progressed to NASH. The NuSirt team is dedicated to improving the lives of those with serious metabolic diseases. We are delighted to have received Fast Track designation, which is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. This designation helps get important new drugs to patients earlier.”
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