09-17-2021

U.S. FDA Grants Key Approvals to Potential Rare and Serious Disease Treatments

The U.S. Food and Drug Administration (FDA) has been actively greenlighting a number of efforts over the last few days to push therapies for rare or serious diseases that have largely unmet medical needs. Here’s a look at today’s approvals. 

SAGE Therapeutics received a Fast Track designation from the FDA for its potential Huntington’s Disease (HD) drug. SAGE-178 is being developed as a treatment for HD after studies showed it helped improve cognitive performance, especially in terms of executive functioning.

“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. 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,” said Jim Doherty, Ph.D., chief research officer at Sage. 

 Pulmocide was also granted a Fast Track designation for opelconazole, its drug candidate for invasive pulmonary aspergillosis. The latter also received Orphan Drug and Qualified Infectious Disease Production designations

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