Sage Therapeutics, Inc. (Nasdaq:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SAGE-718 for development as a potential treatment for Huntington’s disease (HD). Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as HD.
“HD is an autosomal dominant genetic disorder that impacts the brain and by nature numerous generations of a family. Cognitive decline is often one of the earliest signs of the disease and this decline, in addition to other symptoms, results in a devastating impact on independence, general functioning, and quality of life. We believe that improving cognitive function is one of the core paths to maintaining quality of life in HD and remains an area of significant unmet medical need,” said Jim Doherty, Ph.D., chief research officer at Sage Therapeutics. “In studies to date, treatment with SAGE-718 has been associated with improved cognitive performance, particularly in the domain of executive functioning. The FDA Fast Track Designation is an important milestone in the development of SAGE-718, as it provides opportunities to engage collaboratively with the FDA to further clinical development and future regulatory review of SAGE-718 for the treatment of HD.”
Source: Sage Therapeutics