Biogen Canada Inc. announced that Health Canada has granted a Notice of Compliance for ZURZUVAE (zuranolone), the first and only medication approved in Canada for the treatment of moderate or severe postpartum depression in adults. The approval allows the drug to be marketed as a once‑daily, 14‑day oral course, with benefits seen as early as day 3 and sustained through day 45 compared with placebo.
ZURZUVAE is a neuroactive steroid that modulates GABA‑A receptors, offering a novel therapeutic approach distinct from traditional selective serotonin reuptake inhibitors. Its rapid onset of action—benefits observed within three days—and short treatment duration make it a compelling option for patients who need quick relief and a concise course of therapy.
The approval follows a global regulatory trajectory that began with FDA approval in August 2023, UK approval in August 2025, and European Commission approval in September 2025. ZURZUVAE was developed in partnership with Sage Therapeutics, with Biogen holding exclusive commercialization rights outside the U.S. (excluding Japan, Taiwan, and South Korea). Sage was acquired by Supernus Pharmaceuticals in July 2025, but the collaboration remains intact for the Canadian market.
The drug is priced at approximately US$16,000 for a 14‑day course, and Biogen is working with private insurers and a patient support program to facilitate access. Postpartum depression affects up to one in five Canadian women, creating a substantial unmet medical need that ZURZUVAE is positioned to address.
Biogen’s financial performance in 2024 provides context for the significance of this launch. In Q3 2024 the company reported revenue of $2.47 billion, a 3% year‑over‑year decline, and raised its full‑year 2024 adjusted EPS guidance to $16.10‑$16.60. In Q4 2024 revenue rose 3% to $2.5 billion, with non‑GAAP diluted EPS of $3.44, a 17% year‑over‑year increase. ZURZUVAE generated $22 million in revenue in Q3 2024 and $72 million for the full year, a modest but growing contribution relative to Biogen’s $9.7 billion total revenue. The launch therefore represents a new growth engine in a portfolio that has faced headwinds from declining multiple‑sclerosis sales.
Management emphasized the strategic importance of the approval. Eric Tse, General Manager of Biogen Canada, said the drug “addresses a critical unmet need” and that Biogen is focused on expanding its neuroscience and mental‑health portfolio. The approval aligns with Biogen’s broader strategy to diversify beyond its legacy multiple‑sclerosis products and to capitalize on its expertise in neuroactive therapeutics.
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