WASHINGTON D.C.: The US Food and Drug Administration has approved Zurzuvae, an oral pill to treat postpartum depression (PPD) in women, developed by Biogen and Sage Therapeutics.

In addition to postpartum depression, the company is seeking the FDA's approval for Zurzuvae to treat major depressive disorder (MDD), or clinical depression.

Both conditions affect millions of people throughout the world.

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, shortly following scheduling as a controlled substance by the US Drug Enforcement Administration, which is anticipated to occur within 90 days," said Sage Therapeutics and Biogen.

The FDA issued a Complete Response Letter for the New Drug Application for Zurzuvae in the treatment of adults with MDD, which stated that the application did not provide substantial evidence of the effectiveness of Zurzuvae for treating MDD, and additional studies would be needed to support the approval, the statement added.

In response, Sage and Biogen said they were reviewing the feedback and evaluating their next steps.

Meanwhile, the FDA said that treatment for PPD was available only as an intravenous injection.

In 2021, some 21 million adults in the US had at least one episode of MDD, while PPD affects some one in seven women who give birth.