Zurzuvae (zuranolone) becomes first and only MHRA-licensed treatment for mothers with post-natal depression in the UK – Biogen

Biogen announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to zuranolone, an oral capsule licensed for the treatment of adult women with moderate to severe post-natal depression (PND). Zuranolone represents a novel therapeutic approach, offering the first targeted treatment for PND in the U.K., 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 typically take four to six weeks to show effectiveness, though some cases may require up to 12 weeks.

The MHRA submission of zuranolone was underpinned by robust clinical evidence from the NEST development programme, which included two pivotal Phase III trials: the SKYLARK and ROBIN studies. The SKYLARK study evaluated a 14-day course of oral zuranolone 50 mg in women with severe post-natal depression and demonstrated statistically significant and clinically meaningful improvements in depressive symptoms, with effects observed from day 3 and sustained through day 45. The primary endpoint of change from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17) at Day 15 was met. The ROBIN study, which assessed zuranolone 30 mg, also met its primary endpoint and reinforced the consistency of zuranolone’s effects across different dosing regimens. Across both studies, zuranolone was generally well-tolerated, with most reported side effects being mild to moderate in intensity, including somnolence, dizziness, headache, nausea, and diarrhoea. No new safety concerns were identified during the trials.

“This is an important first step in our journey to help address the needs of women experiencing post-natal depression in the UK,” said Kylie Bromley, VP, General Manager UK & Ireland. “We are committed to working with NICE, the SMC and other stakeholders to ensure this treatment becomes accessible to all women who need it. This approval reflects our ongoing drive to make breakthroughs happen in the science of mental health. We are proud to offer a new treatment option developed to help positively impact the lives of women and their families.”

Dr Mano Manoharan, Consultant Perinatal Psychiatrist commented “Postnatal depression affects 1 in 10 mothers, sometimes stigma and poor recognition delay the necessary care. This condition impacts not only mothers but also infants and families. Holistic, evidence-based treatments are vital. The introduction of zuranolone offers a fast-acting, targeted breakthrough to support women swiftly and compassionately”.

See citations- Deligiannidis KM, Meltzer-Brody S et al. Effect of Zuranolone vs Placebo in Postpartum Depression-A Randomized Clinical Trial. JAMA Psychiatry 2021, 78:951 doi:10.1001/jamapsychiatry.2021.1559

Deligiannidis KM, Meltzer-Brody S et al. Zuranolone for the Treatment of Postpartum Depression. Am J Psychiatry. 2023, 180: 668 doi: 10.1176/appi.ajp.20220785