Biogen Secures UK Approval for Oral Postpartum Depression Treatment Zurzuvae

Biogen's Zurzuvae, the first oral treatment for postnatal depression, has been approved in the UK by the Medicines and Healthcare products Regulatory Agency. The drug, which is taken for 14 days, was previously approved by the US FDA in 2023.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Biogen Inc.'s (BIIB) oral treatment, Zuranolone (brand name Zurzuvae), for moderate to severe postnatal depression in adults following childbirth. This marks a significant milestone in the treatment of postnatal depression, which affects an estimated 1 in 10 women in the UK [2].

Zuranolone is the first oral treatment for postnatal depression approved in the UK. It is taken as a capsule at night with a fat-containing meal for 14 days. The drug's rapid 3-day efficacy and 14-day regimen address an unmet need in the treatment of postnatal depression, which is often underdiagnosed and undertreated [2]. The SKYLARK trial, a phase 3 study, demonstrated a 50% reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) scores compared to placebo, with improvements observed within days [1].

The approval in the UK follows Zuranolone's FDA approval in August 2023 in the United States. The drug's first-in-class status and targeted indication position it to capture a substantial share of the growing postnatal depression market, particularly if the National Institute for Health and Care Excellence (NICE) recommends it for routine use [2].

Biogen's success in maternal mental health markets could catalyze the company's long-term growth by diversifying its portfolio beyond neurodegenerative diseases. However, challenges remain, including NICE's cost-effectiveness analysis and potential competition from emerging treatments post-approval [2].

Investors should closely monitor the October 2025 NICE decision, which could serve as a pivotal catalyst for Biogen's long-term value creation in this high-need sector.

References:
[1] MHRA approves zuranolone to treat postnatal depression in adults following childbirth [https://www.gov.uk/government/news/mhra-approves-zuranolone-to-treat-postnatal-depression-in-adults-following-childbirth]
[2] Zuranolone for treating postnatal depression [ID6431] [https://www.nice.org.uk/guidance/indevelopment/gid-ta11356]