Said to be the first and only oral, once-a-day, 14-day treatment, ZURZUVAE can provide quick improvements in depressive symptoms for women with PPD.
Shortly after scheduling as a controlled substance by the US Drug Enforcement Administration, the therapy is anticipated to be launched and will be commercially available in the fourth quarter of this year.
The FDA granted the approval of ZURZUVAE based on the NEST clinical development programme, which included the ROBIN and SKYLARK studies in adult women with PPD.
Both trials achieved their primary endpoint, a reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score at day 15 against placebo.
The FDA also issued a Complete Response Letter (CRL) for zuranolone’s new drug application (NDA) for treating major depressive disorder (MDD) in adults.
In the CRL, the FDA stated that the application failed to provide substantial evidence of effectiveness for supporting zuranolone’s approval to treat MDD and that additional trials will be required.
Sage Therapeutics and Biogen are reviewing the feedback and assessing next steps.
Sage Therapeutics CEO Barry Greene said: “Maternal mental health has been sidelined for far too long, but today’s approval of ZURZUVAE helps to change that.
“In regard to the CRL for MDD, we are highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief. We remain committed to our mission to deliver life-changing brain health medicines.”