FDA OK’s Biogen and Sage’s Zurzuvae for postpartum depression, rejects MDD indication

Biogen and Sage’s postpartum depression drug zuranolone was approved by the FDA, but the companies have set their sights on getting it approved for major depressive disorder as well.

Lecia Bushak

August 7, 2023

4:17 pm

Source: Getty Images.

The Food and Drug Administration made a historic move last week by approving the first oral drug for postpartum depression (PPD).

However, it came in tandem with a rejection of the Biogen and Sage Therapeutics’ New Drug Application (NDA) to use the drug in major depressive disorder (MDD) as well.

Zurzuvae, or zuranolone, was developed by Biogen and Sage Therapeutics and is a once-daily oral pill that is taken for 14 days for PPD. Before Zurzuvae, treatment for PPD involved getting an IV injection at specific healthcare clinics.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child,” noted Tiffany Farchione, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, in a statement accompanying the approval.

Biogen commented on the news, noting it plans to launch Zurzuvae commercially in Q4 of this year.

Still, the company has also set its eyes on moving zuranolone to another indication — the treatment of MDD in adults. Biogen announced that the FDA issued a complete response letter for the NDA and will need more studies on that front.

Still, Biogen CEO Christopher Viehbacher said in a statement that the Zurzuvae approval for PPD is a “major milestone.”

“We believe that Zurzuvae will be an important option to treat PPD and we will thoroughly review the feedback from the FDA on the use of zuranolone in MDD to determine next steps,” Viehbacher said.

The FDA’s decision on Zurzuvae also came shortly after Biogen released its most recent financial and announced plans to cut 1,000 jobs as part of an effort to create $700 million in net operating savings by 2025.

For its part, Sage Therapeutics released its latest earnings report Monday and said that it was “delighted” to receive approval from the FDA for treating postpartum depression with Zurzuvae but added it was “very disappointed” the MDD indication was not greenlit as well. Sage Therapeutics CEO Barry Green said the company would be reviewing the regulatory feedback and evaluating next steps.