Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen (Nasdaq: BIIB) announced that the US Food and Drug Administration has approved ZURZUVAETM (zuranolone) 50 mg for people with postpartum depression (PPD). ZURZUVAE is the first and only oral, once daily, 14-day medication that can significantly lessen depressed symptoms in PPD-affected women. ZURZUVAE is projected to go on sale and be made available to consumers in the fourth quarter of 2023.
The FDA also released a Complete Response Letter (CRL) for the New Drug Application (NDA) for the use of zuranolone in the treatment of adults with major depressive disorder (MDD). In order to support the approval of zuranolone for the treatment of MDD, the CRL noted that the application lacked sufficient evidence of efficacy and that one or more additional studies would be required. Sage and Biogen are considering the comments and possible actions now.
“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,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “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.”
“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,” said Christopher A. Viehbacher, President and Chief Executive Officer at Biogen. “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.”
Based on the NEST clinical development programme, which comprised two trials in adult women with PPD (the ROBIN and SKYLARK trials), ZURZUVAE was approved to treat PPD in women. The 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a widely used indicator of depression severity, significantly decreased from baseline at Day 15 in both studies when compared to placebo. All important secondary objectives in the SKYLARK Study testing ZURZUVAE 50 mg were achieved. Depressive symptoms significantly decreased starting on Day 3 and persisted through Day 45. ZURZUVAE had a consistent safety profile in both investigations and was generally well tolerated. In individuals treated with ZURZUVAE 50 mg, somnolence, dizziness, diarrhoea, weariness, and urinary tract infection were the most frequent side effects >5% and larger than placebo. A boxed warning on the label directs healthcare professionals to inform patients that ZURZUVAE can impair driving since it has central nervous system (CNS) depressive effects. For the duration of the 14-day treatment period, individuals taking ZURZUVAE should not operate a motor vehicle or perform any other potentially risky tasks requiring total mental awareness until at least 12 hours after ZURZUVAE administration. Patients might not be able to gauge how impaired they are.
“Today marks a groundbreaking day for the treatment of PPD, as with ZURZUVAE we now have an oral treatment option that can provide rapid improvements in depressive symptoms in as early as three days for women with PPD,” said Dr. Kristina Deligiannidis, a principal investigator in the ZURZUVAE clinical development program and Professor, The Feinstein Institutes for Medical Research in Manhasset, New York. “As a perinatal psychiatrist, I see the devastating impact PPD has on mothers particularly on the important mother-infant bond and long-term child development. Once available, I believe ZURZUVAE will be a meaningful option for patients in need.”
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
PPD is one of the most prevalent disorders during and after pregnancy, and mental health conditions are the primary cause of maternal mortality, according to the Centres for Disease Control and Prevention. PPD symptoms are thought to affect 1 in 8 women in the United States. Without effective screening, about half of all PPD cases could remain untreated. Only 15.8% of women with PPD symptoms obtain therapy, according to research. PPD symptoms could linger past the time of the baby’s birth and result in prolonged maternal morbidity. Depressed mood, loss of interest in activities, altered sleep and food patterns, decreased energy, feelings of guilt or worthlessness, difficulty focusing, and in some cases suicidal thoughts are some of the symptoms of PPD.
“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.”
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