ZurzuvaeTM (Zuranolone) Becomes First and Only MHRA-Licensed Treatment for Mothers with Post-Natal Depression

Zurzuvae^TM (Zuranolone) Becomes First and Only MHRA-Licensed Treatment for Mothers with Post-Natal Depression

• Post-natal depression (PND) is a significant medical condition that affects one in ten new mothers, with maternal suicide being among the leading causes of death for new mothers in the UK.^1,2
• Zuranolone is the first and only approved medication licensed for the treatment of moderate to severe PND in the United Kingdom.³
• The authorisation of this new therapeutic treatment, introduces a 14-day treatment option for women living with moderate to severe PND, offering rapid relief as early as day three from depressive symptoms.^3-5

Maidenhead, 27^th  August 2025 – Biogen today 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).³ 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.³ This regulatory milestone addresses a critical² , unmet need in maternal health⁶, 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.^1,2,7

PND is a serious medical condition that affects women during late pregnancy and up to 12 months after childbirth.¹ The disease mechanism of PND is distinct from other mental health conditions, though symptoms may appear similar to major depressive disorder (MDD) or baby blues.^1,8-10 The hormonal and neurochemical changes specific to childbirth trigger different brain mechanisms than those seen in MDD, affecting how the condition develops.^8-10

Annually, around 23.8 million women worldwide will experience PND, which has been shown to severely impact a mother's ability to care for herself and her baby.^1,6,11 Characterised by persistent sadness, anxiety, a loss of interest or pleasure in daily activities, sleep disturbances and exhaustion, and in some cases, thoughts of self-harm or harm to the baby lasting more than two weeks.^1,2

Licensed specifically for PND, the mechanism of action of zuranolone provides rapid relief of depressive symptoms through a 14-day treatment course, with symptom relief seen as soon as day three of treatment.^3-5 Zuranolone was generally well tolerated in clinical trials, and notably, there were no reports of weight gain and sexual dysfunction.^3-5 Common side effects include somnolence, dizziness, and fatigue. ^3-5

Beyond the emotional and physical toll, PND imposes a significant economic burden. Anxiety and depression among women during pregnancy and the year after birth, has been shown to incur approximately £75,728 in expenses with each case, nearly three-quarters of which stem from long-term impacts on the child.¹² This amounts to costs of over £4.4 billion to the UK health system per annual birth cohort.^12,13

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”.

 The MHRA submission for zuranolone is supported by data from the NEST clinical development programme. The studies showed that a 14-day course of oral zuranolone led to rapid, statistically significant, and clinically meaningful improvements in depressive symptoms in women with moderate or severe post-natal depression by day three of the treatment course.^3-5 It is generally well-tolerated, with most side effects being mild to moderate.^3-4 Common side effects include somnolence, dizziness, and fatigue. ^3-5

“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.”

Biogen UK are collaborating closely with NICE and the SMC to make zuranolone available on the NHS. NICE’s public consultation on zuranolone will shortly be open for comment.   

*Ends*

Notes to the Editors

About Post-Natal Depression (PND)

Post-natal depression (PND) is a serious and distinct depressive disorder that affects women during late pregnancy and up to 12 months after childbirth.¹ It is characterised by persistent sadness, anxiety, and exhaustion lasting more than two weeks, often continuing for several months if untreated.¹ Unlike the "baby blues", a common, short-lived emotional response affecting up to 80% of new mothers, PND is more severe, longer lasting, and requires clinical intervention.^{1, 14} It also has a distinct pathophysiology, compared to major depressive disorder (MDD), with unique hormonal and neurochemical changes triggered by childbirth.^1,9,10

PND affects approximately 1 in 10 new mothers in the UK, regardless of prior mental health history.¹ Risk factors include pre-existing mental health conditions, complications during pregnancy or delivery, lack of social support, financial stress, and both older and younger maternal age.^1,6 PND can severely impact maternal quality of life, hinder mother-infant bonding, and negatively affect a child’s cognitive, emotional, and social development.¹⁵ Maternal suicide remains the leading cause of death between 6 weeks and one year postpartum in the UK.²

There are currently no medications specifically licensed in the UK for the treatment of PND. NICE guidelines recommend a stepped-care approach based on severity, including non-pharmacological interventions such as guided self-help, cognitive behavioural therapy, and interpersonal therapy for mild to moderate cases.^1,16 For moderate to severe cases, pharmacological treatments including SSRIs and other antidepressants, often in combination with psychological therapies, are prescribed.^1,16

About Zuranolone

Zuranolone is the first and only oral treatment specifically developed and licensed for moderate to severe PND in adults.³ It is a synthetic neuroactive steroid (NAS) that acts as a positive allosteric modulator of GABA-A receptors, enhancing inhibitory signalling in the brain.^3-5 This mechanism helps restore balance in neural networks disrupted by the hormonal and neurochemical changes of childbirth.^3-5

Zuranolone is taken once daily in the evening with food as a , 14-day treatment course.³ Clinical trials (SKYLARK and ROBIN) demonstrated rapid and sustained symptom relief, with significant improvements observed as early as Day 3 and maintained through Day 45.^4,5 It is generally well-tolerated, with most side effects being mild to moderate.^3-5 Common side effects include somnolence, dizziness, and fatigue. ^3-5 Zuranolone has central nervous system depressant effects and potential for abuse. Patients should avoid driving or operating machinery for at least 12 hours after each dose.³ Data from a clinical lactation study indicate that Zuranolone is present in low levels in human breast milk. The calculated maximum relative infant dose (RID) was <1%. The effect on zuranolone on breastfed newborns/infants is unknown and there are limited data on the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zuranolone and any potential adverse effects on the breastfed child from zuranolone or from the underlying maternal condition.³

Zuranolone was granted an Innovation Passport under the MHRA’s Innovative Licensing and Access Pathway (ILAP), recognising its potential to address a significant unmet need in maternal mental health. It will be marketed in the United Kingdom under the brand name Zurzuvae™ to treat PND in adults.³ Outside of the United Kingdom, it is currently approved for use in the United States.

About the NEST Clinical Development Programme

The MHRA submission of zuranolone was underpinned by robust clinical evidence from the NEST development programme, which included two pivotal Phase 3 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 45.⁴ 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.⁵ 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.^4,5

About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

Media Contacts  

Alex Orton-Malyon

Associate Director, Communications and Patient Advocacy

Email address: alex.ortonmalyon@biogen.com

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