FDA Approves Sage Therapeutics/Biogen's Zuranolone For One Type Of Depression, Rejects For Another

The FDA approved Sage Therapeutics Inc SAGE and Biogen Inc's BIIB Zurzuvae (zuranolone) 50 mg for adults with postpartum depression (PPD). 

Zurzuvae is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD. 

Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.

Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023, shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days.

Postpartum depression (PPD) approval is based on results from two Phase 3 trials, ROBIN and SKYLARK studies.

In the SKYLARK Study, treatment with Zurzuvae rapidly improved symptoms of PPD at Day 15 and as early as Day 3 with sustained effect to Day 45.

Also Read: Analyst Creates Bullish Pitch For Sage Therapeutics Around Greater Enthusiasm For Its Depression Drug, Zuranolone.

Additionally, the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder (MDD). 

The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that additional study or studies will be needed. 

Sage and Biogen are reviewing the feedback and evaluating the next steps.

Citing some analysts, Reuters noted that the stocks of both companies might fall if the drug was approved only for postpartum depression due to the smaller patient population.

Price Action: SAGE shares are down 49.60% at $18.10, and BIIB stock is down 2.20% at $263.00 premarket on the last check Monday.