Biogen and Sage Discontinue Plans for Major Depressive Disorder Approval for Zurzuvae

Approval and Discontinuation:
Biogen and Sage Therapeutics have discontinued further development of Zurzuvae for major depressive disorder (MDD) after the FDA rejected its application, citing a need for additional evidence of effectiveness.

Postpartum Depression Approval:
The FDA approved Zurzuvae for postpartum depression (PPD) in August 2023, making it the first oral treatment for this condition.

Market Impact:
The decision to focus on PPD limits the drug's market potential, as MDD is a significantly larger market.

Pricing:
The companies have set a list price of $15,900 for a two-week course of Zurzuvae, which is lower than some analysts predicted and significantly less than Sage’s postpartum depression infusion Zulresso.

Commercial Strategy:
Biogen and Sage plan to start selling Zurzuvae in December 2023, with a more extensive commercial effort beginning in early 2024.

Restructuring:
Sage will discontinue Zulresso and undergo a business restructuring to focus on the launch of Zurzuvae for PPD, shedding about 33% of its workforce.