US FDA approves world’s first pill for post-partum depression
- Makers Biogen and Sage Therapeutics had sought approval for the drug, Zurzuvae, to treat major depressive disorder as well, which affects millions
- PPD severely affects a mother’s ability to return to normal functioning, while also potentially having an impact on her relationship with her child
The US Food and Drug Administration (FDA) on Friday approved Biogen and Sage Therapeutics’ oral pill to treat post-partum depression (PPD) in adults.
The companies had sought the FDA’s approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as post-partum depression, which affect millions of people.
PPD severely affects a woman’s ability to return to normal functioning, while also potentially affecting the mother’s relationship with her child.
“Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 soon following scheduling as a controlled substance by the US Drug Enforcement Administration, which is anticipated to occur within 90 days,” Sage Therapeutics and Biogen said in a statement.
The statement said the FDA issued a Complete Response Letter for the New Drug Application for Zurzuvae in the treatment of adults with MDD. The letter said the application did not provide substantial evidence of the effectiveness of Zurzuvae for treating of MDD and that additional studies would be needed to support the approval.