The United States’ Food and Drug Administration (FDA) has approved Biogen (BIIB.O) and Sage Therapeutics’ (SAGE.O) oral pill to treat postpartum depression (PPD) in adults.
Recall that the companies had sought the FDA’s approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people.
According to experts, PPD severely affects a woman’s ability to return to normal functioning, while also potentially affecting the mother’s relationship with her child.
Sage Therapeutics and Biogen said in a statement “Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days”.
According to the statement, 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.
Sage and Biogen said they were reviewing the feedback and evaluating next steps.
Analysts have anticipated that the stocks of both companies would fall if the drug was approved only for postpartum depression, due to the smaller patient population.
Recall that before now, the FDA said treatment for postpartum depression was available only as an intravenous injection.
It could also be recalled that in 2021, an estimated 21 million adults in the United States had at least one episode of major depressive disorder, which is characterized by a persistent feeling of sadness. Official records have it that PPD affects around one in seven women who give birth.
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