Sage, Biogen obtain FDA OK for Zurzuvae
Sage Therapeutics and Biogen have received permission from the Food and Drug Administration for Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression in adults.
Zurzuvae is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD, the companies said.
Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the Drug Enforcement Administration, which is anticipated to occur within 90 days, the companies noted.
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PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain healthcare facilities.
"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 also can have consequences for the child's physical and emotional development," said Tiffany Farchione, 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."
As with other forms of depression, PPD is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure. It can present with symptoms such as cognitive impairment, feelings of sadness or inadequacy, loss of energy or suicidal ideation.
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Additionally, the FDA issued a Complete Response Letterfor the New Drug Application for zuranolone in the treatment of adults with major depressive disorder. 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. Sage and Biogen are reviewing the feedback and evaluating 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, CEO 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 Viehbacher, president and CEO 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.”
"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 Davis, 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.