Zuranolone is the first oral treatment for postnatal depression approved in the UK, the agency said.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday said that it has approved Biogen Inc.’s (BIIB) Zuranolone to treat moderate or severe postnatal depression (PPD) in adults following childbirth.
Postnatal depression is a type of depression that many parents experience after having a baby and is marked by feelings of sadness, irritability, anxiety, loss of interest, extreme fatigue, appetite changes, among others. One in every ten women is affected by postnatal depression within a year of childbirth, as per MHRA.
Biogen’s Zuranolone, under the brand name Zurzuvae, is the first oral treatment for postnatal depression approved in the UK, the agency said.
The drug comes as a capsule and should be taken orally at night with a fat-containing meal for 14 days. Common side effects of the medicine include memory impairment, confusion, and fatigue, among others.
On Stocktwits, retail sentiment around BIIB stock trended within the ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘normal’ levels.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Zurzuvae last month in the European Union. The drug was approved by the U.S. Food and Drug Administration in 2023. According to Biogen, an estimated 5-20% of women with a pregnancy experience symptoms of PPD in Europe.
Zurzuvae was discovered by Sage Therapeutics Inc. (SAGE). In 2020, Biogen and Sage Therapeutics entered into a collaboration to jointly develop and commercialize Zurzuvae in the U.S. As part of the agreement, Biogen received exclusive rights to develop and commercialize Zurzuvae outside of the U.S., excluding Japan, Taiwan, and South Korea.
In the second quarter, Biogen reported revenue of $46.4 million from Zurzuvae, up from $14.9 million in the corresponding quarter of 2024, driven by increased demand.
BIIB stock is down by 10% this year and by about 32% over the past 12 months.
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