FDA Approves Biogen’s Drug for Postpartum Depression

Biogen and its collaboration partner Sage Therapeutics have announced that the FDA has approved Zurzuvae (zuranolone) for adults with postpartum depression (PPD). Zurzuvae is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD. 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.

Additionally, the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder (MDD). The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed. Biogen and Sage are reviewing the feedback and evaluating next steps.

According to the CDC, mental health conditions are the leading cause of maternal mortality with PPD among the most common complications during and after pregnancy. In the U.S., it is estimated approximately 1 in 8 women experience symptoms of PPD. Approximately half of all PPD cases may go undiagnosed without appropriate screening. Research shows only 15.8% of women with PPD symptoms receive treatment. PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidity. Symptoms of PPD can include depressed mood, loss of interest in activities, changes in sleep patterns and appetite, decreased energy, feelings of guilt or worthlessness, trouble concentrating and in some cases thoughts of suicide.

“Today’s approval is welcome news for the estimated 500,000 women in the United States who report experiencing symptoms of this devastating and often misunderstood illness each year,” said Wendy N. Davis, Ph.D., PMH-C, Executive Director at Postpartum Support International. “Women with PPD desperately need prompt care and additional treatment options that can provide quick relief so they can be healthy and present during this momentous time in their lives.” (Source: Biogen Website, 04 August, 2023)