Source – Biogen
Biogen and Sage Therapeutics have received FDA approval for Zurzuvae (zuranolone) 50 mg, a breakthrough treatment for postpartum depression (PPD) in adults. Zurzuvae is the first oral, once-daily, 14-day medication that provides rapid relief from depressive symptoms in women with PPD. The drug is expected to be commercially available in the fourth quarter of 2023, shortly after the US. Drug Enforcement Administration schedules it as a controlled substance, which is estimated to happen within 90 days.
“Maternal mental health has been sidelined for far too long, but today’s approval of Zurzuvae helps to change that. Women have been waiting for an oral medicine that can specifically and rapidly improve the symptoms of PPD and we are proud to be able to deliver that. In regard to the CRL for MDD, we are highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief. We remain committed to our mission to deliver life-changing brain health medicines.”
– Barry Greene, Chief Executive Officer at Sage Therapeutics
However, the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) in adults. The CRL indicated that the application lacked sufficient evidence of effectiveness to support zuranolone’s approval for MDD treatment, and further studies will be required. Biogen and Sage are now reviewing the feedback and considering their next steps.
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The approval of Zurzuvae to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition. We appreciate the support of patients, patient advocates and researchers who helped to reach this milestone. We believe that ZURZUVAE will be an important option to treat PPD and we will thoroughly review the feedback from the FDA on the use of zuranolone in MDD to determine next steps.”
– Christopher A. Viehbacher, President and Chief Executive Officer at Biogen
The approval of Zurzuvae is based on the successful NEST clinical development program, which included two studies (ROBIN and SKYLARK) in adult women with PPD. Both studies demonstrated a significant reduction in depression severity, as measured by the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, at Day 15 compared to placebo. The SKYLARK Study, evaluating Zurzuvae 50 mg, showed rapid and sustained improvement in depressive symptoms, with significant reductions seen as early as Day 3 and continuing through Day 45. The drug was generally well-tolerated, with somnolence, dizziness, diarrhoea, fatigue, and urinary tract infection as the most common side effects.
It is estimated that about 1 in 8 women in the US experience symptoms of PPD, with half of the cases potentially going undiagnosed without proper screening. PPD is a significant cause of maternal mortality, and only a small percentage of women with PPD symptoms receive treatment. The approval of Zurzuvae offers hope for women struggling with PPD and may help improve maternal health outcomes in the United States. However, healthcare providers must advise patients that Zurzuvae can cause driving impairment due to its central nervous system (CNS) depressant effects, and patients should avoid driving or engaging in potentially hazardous activities for at least 12 hours after taking the medication during the 14-day treatment course.
