First post-natal depression drug approved in UK

US biotech major Biogen (Nasdaq: BIIB) announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization to Zurzuvae (zuranolone), an oral capsule licensed for the treatment of adult women with moderate to severe post-natal depression (PND).

Biogen noted that Zuranolone represents a novel therapeutic approach, offering the first targeted treatment for PND in the UK, with a mechanism of action distinct from traditional antidepressants. This regulatory milestone addresses a critical, unmet need in maternal health, where the current standard of care for PND involves psychological interventions, such as talking therapies and off-label use of antidepressants that that typically taken four to six weeks to show effectiveness, though some cases may require up to 12 weeks.

Zurzuvae was approved and launched in the USA at end 2023 and generated sales of $74.1 million in second-quarter 2025, up 171% year-on-year, for the company. The drug has also recently been recommended for approval in Europe.