HQ Team
August 28, 2025: Biogen Inc., a US-based biotechnology company, got a nod from Britain’s medicines regulator for its drug to treat postnatal depression in adults.
The Medicines and Healthcare products Regulatory Agency (MHRA) approved zuranolone, branded as Zurzuvae, to treat moderate or severe postnatal depression in adults following childbirth, according to a statement.
Zuranolone is the first oral treatment for postnatal depression approved in the UK. The MHRA conducted a “rigorous assessment of the safety, quality, and efficacy of zuranolone.”
Postnatal depression is a type of depression that many parents experience after having a baby. It is a common problem, affecting more than one in every 10 women within a year of giving birth.
Disturbed sleep patterns
Common symptoms of postnatal depression include persistent feelings of sadness or inadequacy, irritability, anxiety about their baby’s well-being, and loss of interest in previously enjoyable activities, accompanied by physical manifestations such as extreme fatigue, disrupted sleep patterns, and changes in appetite.
Zurzuvae comes as a capsule and is taken orally, at night with a fat-containing meal for 14 days.
“The approval of zuranolone reflects our ongoing commitment to increasing access to new medicines that have the potential to make a real difference to people suffering from serious health issues, and that have proven safety, quality and efficacy recognised by comparable international regulators,” said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.
“We are assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep the safety of zuranolone under close review.”
The most common side effects of zuranolone include memory impairment, confusion, somnolence (drowsiness), dizziness, sedation, tremor, diarrhoea, and fatigue.
Fetal harm
The product information contains important warnings about the risk of suicidal behaviour and withdrawal reactions, as well as its sedative properties affecting the ability to drive.
Zuranolone may cause fetal harm and is contraindicated during pregnancy. Women should use effective contraception while taking the medicine, and for one week after taking the drug, according to the statement.
