WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Friday approved Biogen (BIIB.O) and Sage Therapeutics’ (SAGE.O) oral pill to treat postpartum depression (PPD) in adults.
The companies had sought the FDA’s approval for the drug, Zurzuvae, to treat major depressive disorder), or clinical depression, as well as postpartum depression (PPD), 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.
Analysts were anticipating the stocks of both companies to fall if the drug was approved only for postpartum depression due to the smaller patient population.
Until now, the FDA said, treatment for postpartum depression was available only as an IV injection.
In 2021, an estimated 21.0 million adults in the United States had at least one episode of major depressive disorder, which is characterized by a persistent feeling of sadness. Postpartum depression (PPD) affects around one in seven women who give birth.
Reporting by Sriparna Roy and Lavanya Ahire in Bengaluru; Editing by Krishna Chandra Eluri and Leslie Adler