ZURZUVAE receives positive CHMP opinion for postpartum depression treatment

Biogen Inc. (NASDAQ: BIIB) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorization for ZURZUVAE (zuranolone) for treating postpartum depression in adults following childbirth.

If approved by the European Commission, ZURZUVAE would become the first treatment authorized within the European Union specifically indicated for depressive symptoms in women with postpartum depression. The drug is a once-daily, oral, 14-day treatment that received U.S. Food and Drug Administration approval in August 2023.

The CHMP recommendation is based on the SKYLARK Study, which met its primary endpoint of significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression total score at Day 15 compared to placebo. The study also met all key secondary endpoints, with significant reduction in depressive symptoms observed as early as Day 3 and sustained through Day 45 compared to placebo.

The most frequently reported side effects occurring in 5% or more of patients and greater than placebo were somnolence, dizziness, and sedation. ZURZUVAE was generally well-tolerated in the study.

An estimated 5-20% of women with a pregnancy in Europe experience symptoms of postpartum depression, according to the press release. The condition remains both underdiagnosed and undertreated due to varying clinical guidelines for screening and management across European countries.

The European Commission will now review the CHMP recommendation for marketing authorization, with a final decision expected in the third quarter of 2025. The Drug Enforcement Agency scheduled ZURZUVAE as a Class IV controlled substance in October 2023.

ZURZUVAE was discovered by Sage Therapeutics Inc. (NASDAQ: SAGE). In 2020, Biogen and Sage Therapeutics entered into a collaboration agreement, with Biogen receiving exclusive rights to develop and commercialize the drug outside the U.S., excluding Japan, Taiwan and South Korea.

You May Also Be Interested In

• SpaceX files for 555.56M share IPO at $135/sh
• Aeva Technologies launches $100 million follow-on stock offering
• 3 E Network Technology (MASK) files for 17.13M share offering by selling stockholders