The Food and Drug Administration has granted fast track status to volixibat, an investigational treatment manufactured by Shire.
“The FDA’s fast track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need,” the Dublin-based pharmaceutical company explained in a statement. “However, it does not guarantee that the FDA will ultimately approve [volixibat] for NASH [nonalcoholic steatohepatitis] or the timing of any such approval.”
Volixibat, also known as SHP626, is meant to treat NASH with liver fibrosis in adult patients via an apical sodium-dependent bile acid transporter inhibitor, which is a protein that recycles bile acids from the intestine and into the liver. This orally administered, once-daily treatment would be the first ever treatment available for NASH.
“This fast track designation is further recognition of the critical need to develop new, effective therapeutic options for patients with this serious condition,” said Philip J. Vickers, PhD, head of research and development for Shire, in a statement.
Preclinical and phase I studies have already been completed, the results of which contributed to the FDA granting volixibat fast track status. A randomized, placebo-controlled, double-blind phase II trial is set to get underway shortly at centers in the United States, Canada, and the United Kingdom, which will examine safety, tolerability, and efficacy of a three-dose volixibat regimen administered over the course of 48 weeks.