FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced the U.S. Food and Drug Administration (FDA) approved ZURZUVAE™ (zuranolone) 50 mg 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.
“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.”
“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 women with PPD is based on the NEST clinical development program, which included two studies in adult women with PPD (ROBIN and SKYLARK Studies). Both studies met their primary endpoint, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a common measure of depression severity, at Day 15 as compared to placebo. In the SKYLARK Study evaluating ZURZUVAE 50 mg, all key secondary endpoints were met, with significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45. ZURZUVAE was generally well-tolerated with a consistent safety profile across both studies. The most common side effects ≥ 5% and greater than placebo in patients treated with ZURZUVAE 50 mg were somnolence, dizziness, diarrhea, fatigue and urinary tract infection. The labeling includes a boxed warning that instructs healthcare providers to advise people that ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects. People who take ZURZUVAE should not drive a motor vehicle or engage in other potentially hazardous activities that require complete mental alertness until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Patients may not be able to assess their own degree of impairment.
“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.”
According to the Centers for Disease Control and Prevention, mental health conditions are the leading cause of maternal mortality1 with PPD among the most common complications during and after pregnancy.2 In the U.S., it is estimated approximately 1 in 8 women experience symptoms of PPD.3 Approximately half of all PPD cases may go undiagnosed without appropriate screening.4,5 Research shows only 15.8% of women with PPD symptoms receive treatment.6 PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidity.7-9 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
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