Biogen Receives Health Canada Authorization for ZURZUVAE™ (zuranolone), the First and Only Treatment Indicated for Adults with Postpartum Depression in Canada

Key Terms

postpartum depression medical

A mood disorder that can arise after childbirth, characterized by persistent sadness, anxiety, exhaustion and difficulty caring for oneself or a baby; it can range from moderate to severe and often requires medical or therapeutic treatment. Investors care because its prevalence affects demand for medical treatments, mental-health services and parental workplace policies, and can influence healthcare spending, drug development programs, and productivity in sectors that depend on caregiver labor — much like a widespread recurring expense that changes consumer and employer behavior.

Hamilton Rating Scale for Depression (HAMD-17) medical

A 17-question clinical rating scale used to measure the severity of a person’s depressive symptoms based on a clinician’s observations and patient reports. Investors watch HAMD‑17 scores because shifts in the average score are often the primary way drug and therapy trials show benefit or harm; like a thermometer or test grade, it translates patient experience into a single, comparable number that can drive regulatory decisions, market expectations, and valuation.

• Postpartum depression (PPD) affects up to one in five Canadian women¹; it is the most common complication² related to childbearing and a leading cause of maternal death in Canada³
• Left untreated, PPD can have short- and long-term consequences on maternal health, child development and family well-being^4,5,6
• ZURZUVAE is a 14-day, oral single course of treatment that offers relief from depressive symptoms as early as Day 3, a significant step forward from the current standards of PPD care

TORONTO--(BUSINESS WIRE)-- Biogen Canada Inc. today announced that Health Canada has issued a Notice of Compliance (NOC) for ZURZUVAE^™ (zuranolone) for the treatment of moderate or severe postpartum depression (PPD) in adults following childbirth. ZURZUVAE is a once-daily, 14-day oral single course treatment for women with PPD. This first-of-its-kind treatment offers relief from depressive symptoms, with benefits seen in clinical studies as early as day 3, significant reduction of symptoms by the end of treatment at Day 15, and sustained effect through day 45 compared to placebo.

ZURZUVAE offers a novel therapeutic approach due to its onset as early as Day 3 and a targeted mode of action that addresses mood dysregulation thought to be related to the significant hormone fluctuations after childbirth^7,8. Unlike traditional antidepressants, which target serotonin pathways, ZURZUVAE modulates the activity of gamma-aminobutyric acid A (GABAA) receptors in the brain, whose signaling is involved in the regulation of mood^7,8. By enhancing the activity of GABA, ZURZUVAE may help restore function in the dysregulated parts of the brain causing depressive symptoms.^8,9

“A treatment developed specifically for postpartum depression marks an important step forward for maternal mental health,” said Dr. Crystal Clark, MD, MSc, Canada Research Chair in Reproductive Mental Health and Associate Head of Research, Department of Psychiatry, Women’s College Hospital. “Postpartum depression is often driven by profound hormonal shifts that occur during and after childbirth, and expanding treatment options with a therapy designed to address the impact of these biological changes on mental health addresses a longstanding gap in medical care. For postpartum individuals — who are caring for a newborn while managing major hormonal, physiological, and life transitions — ZURZUVAE offers a quick-acting, 14-day treatment, and new hope for reducing the debilitating burden of depression and improving family outcomes."

PPD is a common, serious maternal mental health issue that starts during or after pregnancy.⁹ Symptoms may include depressed mood, anxiety, functional impairment of daily activities, feelings of guilt and worthlessness, doubts about motherhood, and thoughts of self- or infant harm.⁴ It can have debilitating short- and long-term impacts on both the mother and child. Left untreated, PPD can affect a mother and baby’s ability to bond, impacting the baby’s sleep, feeding, and long-term development, and is linked to a higher risk of anxiety and depression later in life.⁴ PPD also has a ripple effect on families and society with links to lower marital satisfaction, higher separation rates^{9, 10}, as well as higher levels of stress, anxiety and depression in partners.⁴

“There are notable gaps across the country with respect to the diagnosis, treatment and care of post-partum depression, which can have a devastating impact on mothers and families,” said Claire Zlobin, Founder, Life With a Baby. “We must make maternal mental health a national priority and elevate the standards of care. Ignoring these issues costs Canada over an estimated $6 billion in healthcare, social services and lost productivity costs each year.¹¹ We welcome the news of a new treatment option specifically developed for post-partum depression as an important step in supporting mothers and babies.”

The approval of ZURZUVAE is based on the NEST clinical development program, which included the 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. The SKYLARK study additionally showed statistically significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45 compared to placebo. ZURZUVAE was generally well-tolerated with a consistent safety profile across both studies. The most frequently reported side effects ≥ 10% in ZURZUVAE (50mg) and > 2% than placebo were somnolence, dizziness, and sedation.

“This approval addresses a critical unmet need for Canadian mothers, marking an important step in elevating how we treat what can be a devastating maternal health issue,” said Eric Tse, General Manager, Biogen Canada Inc. "To any mother experiencing postpartum depression, prompt symptom relief and return to more normal functioning is critical. For the first time, mothers will have access to effective treatment, specifically indicated for PPD. This innovation builds on Biogen’s proven history of pioneering first-in-class treatments for unmet medical needs, and we are working collaboratively with decision-makers across Canada to enable timely access to ZURZUVAE.”

ZURZUVAE is available in the U.S. with coverage through most major insurers¹². The U.S. Food and Drug Administration (FDA) approved ZURZUVAE in August 2023 and the Drug Enforcement Agency (DEA) scheduled it as a Class IV controlled substance in October 2023. ZURZUVAE received regulatory approvals in the U.K. by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission in August and September 2025, respectively.

About ZURZUVAE ^™ (zuranolone)

ZURZUVAE^™ is a neuroactive steroid (NAS) that acts as a positive allosteric modulator of GABA-A receptors, enhancing inhibitory signalling in the brain. The GABA system is the major inhibitory signaling pathway of the central nervous system and contributes to regulating brain function.

ZURZUVAE was discovered by Sage Therapeutics, Inc., and in 2020 Biogen and Sage Therapeutics entered into a collaboration to jointly develop and commercialize ZURZUVAE in the U.S. As part of the agreement, Biogen received exclusive rights to develop and commercialize ZURZUVAE outside of the U.S., excluding Japan, Taiwan and South Korea. In July 2025, Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) completed its acquisition of Sage Therapeutics and is now the collaboration partner with whom Biogen is working in the U.S.

About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment, to deliver long-term growth.

Biogen has been proudly serving Canadian patients for more than 25 years. For information about Biogen Canada, please visit www.biogen.ca.

References:

1. Vigod SN, Frey BN, Clark CT, Grigoriadis S, Barker LC, et al. Canadian Network for Mood and Anxiety Treatments 2024 clinical practice guideline for the management of perinatal mood, anxiety, and related disorders. Canadian Journal of Psychiatry. 2025. Available at: https://journals.sagepub.com/doi/full/10.1177/07067437241303031.
2. Centre for Addiction and Mental Health. Postpartum Depression: Clinical Overview. 2025. Available at: https://www.camh.ca/-/media/files/ppd_clinical_overview-pdf.pdf.
3. Campbell, J., Cuthbert, C., Deave, T. et al. J. Women’s Health 30, 236–244 (2021)
4. Moore Simas TA, Huang M-Y, Patton C, Reinhart M, Chawla AJ, Clemson C, Eldar-Lissai A. The humanistic burden of postpartum depression: a systematic literature review. Current Medical Research and Opinion. 2019;35(3):383-393. Available at: https://doi.org/10.1080/03007995.2018.1552039.
5. Rogers A, Holbrook K, et al. Association between maternal perinatal depression and anxiety and child and adolescent development: a meta-analysis. JAMA Pediatrics. 2020;174(11):1082-1092. Available at: https://jamanetwork.com/journals/jamapediatrics/fullarticle/2770120.
6. Goodman JH. Paternal postpartum depression, its relationship to maternal postpartum depression, and implications for family health. Journal of Advanced Nursing. 2004;45(1):26-35. Available at: https://onlinelibrary.wiley.com/doi/abs/10.1046/j.1365-2648.2003.02857.x.
7. ZURZUVAE Product Monograph, December, 2025
8. Maguire J. Neuroactive steroids and GABAergic involvement in the neuroendocrine dysfunction associated with major depressive disorder and postpartum depression. Frontiers in Cellular Neuroscience. 2019. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC6418819/.
9. Letourneau NL, Dennis CL, Benzies K, Duffett-Leger L, Stewart M, Tryphonopoulos PD, Este D, Watson W. Postpartum depression is a family affair: addressing the impact on mothers, fathers, and children. Issues in Mental Health Nursing. 2012;33(7):445-457. Available at: https://pubmed.ncbi.nlm.nih.gov/22757597/.
10. Kerstis B, et al. Association between parental depressive symptoms and impaired bonding with the infant. Archives of Women’s Mental Health. 2016;19(1):87-94. Available at: https://pubmed.ncbi.nlm.nih.gov/25854998/.
11. Canadian Perinatal Mental Health Collaborative. Time for action: Why Canada needs a national perinatal mental health strategy now more than ever. Ottawa, Canada: Canadian Perinatal Mental Health Collaborative; 2021. 48 p.
12. Policy Center for Maternal Mental Health. One year later: How insurers are covering Zurzuvae, the first postpartum depression pill. 2024. Available at: https://policycentermmh.org/one-year-later-how-insurers-are-covering-zurzuvae-the-first-postpartum-depression-pill/.

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MEDIA

Biogen

Marija Mandic

+1 416 234 7901

can-canadacommunications@biogen.com

Source: Biogen Canada Inc.