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news.The US Food and Drug Administration (FDA) has approved Israel-based Galmed Pharmaceuticals' request for fast track designation of its product candidate, aramchol, indicated to treat Non-Alcoholic Steato-Hepatitis (NASH), a chronic disease.
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The FDA fast track status helps in expediting the review and development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.
According to scientific literature, NASH affects about 12% of the population in US and in certain European Union (EU) nations, and its prevalence is expected to increase in parallel with increased rates of obesity and diabetes.
Currently, there are no approved drugs for the treatment of NASH.
Later this year, the company intends to initiate a Phase IIb clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance in Israel, Europe and certain Latin American countries.
Galmed chief executive officer Allen Baharaff said: "The Fast Track Designation of aramchol will allow for continued contact between Galmed and the FDA to optimally design aramchol’s future studies, including clinical trials in the United States, and may enable Galmed to accelerate its development, FDA approval and the time to market."
In July 2014, the FDA cleared the company’s investigational new drug (IND) application for aramchol.
Galmed is focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones.