Wedoany.com Report-Dec.11, Biogen Canada Inc. has received a Notice of Compliance from Health Canada for Zurzuvae (zuranolone), marking the first oral treatment specifically authorised for moderate to severe postpartum depression in adults in the country. The approval was announced on 9 December 2025.

The once-daily oral therapy is intended for the treatment of PPD.

Zurzuvae is administered as a once-daily oral medication for 14 days. Clinical studies showed symptom improvement as early as day three, with substantial reductions by day 15, and benefits sustained through day 45 compared to placebo.

The medication works by modulating gamma-aminobutyric acid A (GABAA) receptors in the brain to support mood regulation, differing from traditional antidepressants that primarily affect serotonin pathways.

Health Canada's decision was based on data from the NEST clinical programme, including the SKYLARK and ROBIN trials. In both studies, participants experienced a significant decrease in Hamilton Rating Scale for Depression (HAMD-17) scores at day 15 compared to placebo. The SKYLARK trial also demonstrated early symptom relief from day three, maintained through day 45.

Zurzuvae was generally well-tolerated in trials, with the most frequent side effects being somnolence, dizziness, and sedation.

Biogen Canada General Manager Eric Tse stated: "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. 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."

Biogen is partnering with private insurers to secure coverage and has established patient support programmes to assist with access, including navigation of reimbursement processes and financial aid where applicable.

Zurzuvae is expected to become available in Canada early in 2026. The treatment has already received regulatory approval in the United States, United Kingdom, and European Union.

In a related development, in November 2025, Eisai and Biogen announced that the UK Medicines and Healthcare products Regulatory Agency approved Leqembi (lecanemab) for intravenous maintenance dosing every four weeks for early Alzheimer's disease. This update complements the existing biweekly dosing regimen, providing greater flexibility for patients and caregivers while maintaining efficacy in slowing cognitive decline. The approval expands treatment options in the UK, where Leqembi was initially authorised in August 2024.

Biogen continues to focus on addressing unmet needs in neurological and maternal health conditions, with ongoing efforts to ensure broad access to innovative therapies like Zurzuvae across Canada. Healthcare providers are encouraged to discuss this new option with eligible patients to support timely intervention for postpartum depression.