Sage and Biogen Initiate Rolling Submission of NDA to US FDA for Zuranolone to Treat Major Depressive Disorder
Shots:
- The company has initiated a rolling submission of NDA to the US FDA for zuranolone to treat MDD. The NDA submission for MDD is expected to complete the remaining component in H2’22 & for PPD in H1’23
- The NDA was based on the (LANDSCAPE) & (NEST) programs, including the (SHORELINE) study & data from the completed clinical pharmacology studies. The results from the (LANDSCAPE) & (NEST) programs showed rapid & sustained effects along with a well-tolerated safety profile in clinical trials
- The companies have submitted the nonclinical module of the NDA to the US FDA. Zuranolone is an investigational oral NAS GABA-A receptor PAM & has received the FTD from the US FDA in 2017 in MDD & BTD in 2018
Ref: Businesswire | Image: Biogen
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