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Sage and Biogen Initiate Rolling Submission of NDA to US FDA for Zuranolone to Treat Major Depressive Disorder

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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

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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