Biogen has received marketing authorization from the European Commission for Zurzuvae (zuranolone) for postpartum depression (PPD).
Zurzuvae is a neuroactive steroid GABA-A receptor positive allosteric modulator, taken orally once-daily for 14 days. It received approval from the EC after meeting its primary end point in the Skylark study, with a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) compared to the placebo. Zurzuvae also met all the key secondary endpoints and was generally well tolerated. To date, it is the only treatment indicated for PPD in the EU.
In the U.S., Biogen and partner Sage Therapeutics won FDA approval for Zurzuvae in August 2023, but failed to secure approval in major depressive disorder, a larger indication.