The U.S. Food and Drug Administration (FDA) has given fast track designation to Prilenia Therapeutics’ pridopidine as a potential oral treatment for Huntington’s disease.
This designation is given to therapies that show considerable potential in addressing serious conditions for which available treatments fall short. It is meant to speed their clinical development and regulatory review — enabling a rolling review and qualification for accelerated approval and priority review.
Rolling review means the company can submit sections of the regulatory application for review as they come ready, rather than waiting for every section to be completed before the application can be reviewed by the agency.
“Receipt of Fast Track designation from the FDA underscores the urgency to address a significant unmet need for patients with Huntington’s Disease,” Michael R. Hayden, PhD, Prilenia’s CEO and founder, said in a press release.
Huntington’s “is one of the most devastating neurodegenerative disorders, impacting not only patients but their families,” Hayden said, adding that “at the present time, there is no approved treatment to delay onset or slow disease progression.”
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