FDA Places Prilenia’s Oral Pridopidine on Fast Track

FDA Places Prilenia’s Oral Pridopidine on Fast Track

312711

FDA Places Prilenia’s Oral Pridopidine on Fast Track

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…

You must be logged in to read/download the full post.