Prilenia Receives Fast Track Designation for Pridopidine for the Treatment of Huntington’s Disease (HD); Pridopidine Also Granted Orphan Drug Status for Treatment of HD

On November 17, 2021, Prilenia Therapeutics B.V., a clinical-stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pridopidine for development as a potential treatment for Huntington’s Disease (HD). Fast Track is a process designed to facilitate the development and expedite the review of new treatments for serious conditions with unmet medical need such as HD. Drugs that receive Fast Track designation may be eligible for more frequent communications with the FDA to review the drug's development plan, including the extent of data needed for approval. Drugs with Fast Track designation may also qualify for accelerated approval and priority review of new drug applications.

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