The U.S. Food and Drug Administration (FDA) has granted approval for Biogen and Sage Therapeutics’ oral pill, Zurzuvae, to treat postpartum depression (PPD) in adults. This milestone came after the companies sought FDA approval for the drug, intending to address both major depressive disorder (MDD) and postpartum depression, conditions that impact a significant number of people.
Postpartum depression poses a severe challenge for women, hindering their ability to resume normal functioning and potentially affecting their relationship with their child. With Zurzuvae’s approval, a new treatment option is available to address this critical aspect of maternal health.
According to a statement from Sage Therapeutics and Biogen, Zurzuvae is expected to launch and become commercially available in the fourth quarter of 2023, shortly after obtaining scheduling as a controlled substance by the U.S. Drug Enforcement Administration (DEA). This scheduling process is anticipated to take approximately 90 days.
While the FDA approved Zurzuvae for postpartum depression, it issued a Complete Response Letter for the New Drug Application concerning the treatment of adults with MDD. The letter highlighted that the application did not provide sufficient evidence of Zurzuvae’s effectiveness in treating MDD, requiring additional studies to support its approval for this indication.
Sage and Biogen are currently reviewing the feedback provided by the FDA and evaluating their next steps regarding the MDD indication.
Market analysts had anticipated that the stocks of both companies might decline if the drug received approval solely for postpartum depression, mainly due to the smaller patient population associated with this condition.
Prior to this approval, the available treatment options for postpartum depression were limited to intravenous injections. Zurzuvae’s oral formulation provides a more convenient and accessible option for affected individuals.
In the United States alone, an estimated 21 million adults experienced at least one episode of major depressive disorder in 2021, characterized by persistent feelings of sadness. Additionally, postpartum depression affects approximately one in seven women who give birth, underscoring the significance of having an effective treatment option to address this condition.