A fast-acting depression pill from Biogen Inc. and Sage Therapeutics Inc., the first specifically intended to treat postpartum depression, was cleared for the market by US regulators.
(Bloomberg) — A fast-acting depression pill from Biogen Inc. and Sage Therapeutics Inc., the first specifically intended to treat postpartum depression, was cleared for the market by US regulators.
The drug, which will be sold as Zurzuvae, is designed to help people feel better in a matter of days, instead of weeks like most commonly used antidepressants. It’s meant to be taken for only two weeks. The FDA approved the drug, granting the application priority review and fast track designation.
“Postpartum depression is a serious and potentially life-threatening condition,” said Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
The partners see a big opportunity. An estimated 21 million adults in the US experienced at least one major depressive episode in 2020, according to a National Institutes of Health estimate. About one in eight new mothers experiences postpartum depression, according to the Centers for Disease Control and Prevention.
Zurzuvae, a daily pill, helped people feel better within days in clinical trials. However, the drug has faced questions about whether the improvement lasts once people stop taking it. That could limit interest from doctors and insurers, especially with cheap generic drugs so embedded into the current treatment.
Biogen and Sage will also need to raise awareness of postpartum depression. Although it’s common, one study found only about half of women with the condition are diagnosed and only about 10% are adequately treated. Sage sells an infused drug similar to Zurzuvae that’s struggled to gain traction.
Kristina Deligiannidis, a principal investigator on Zurzuvae’s postpartum depression clinical trials, thinks this time will be different since women will be more interested in taking a pill every day for two weeks rather than sitting through a nearly three-day infusion.
“This is really going to change the way we treat postpartum depression,” said Deligiannidis, director of women’s behavioral health at Northwell Health’s Zucker Hillside Hospital.
It’s possible Zurzuvae will be used to kickstart treatment and then be augmented with traditional antidepressants to ensure relief, said Samantha Meltzer-Brody, director of the University of North Carolina’s Center for Women’s Mood Disorders. Women in the postpartum trials continued feeling better for 45 days, but they weren’t tracked beyond that, so doctors may want the security of a treatment that’s known to work long-term, said Meltzer-Brody.
Before Biogen and Sage can start selling Zurzuvae, they’ll need clearance from the Drug Enforcement Administration, which categorizes certain drugs based on their potential for abuse. The companies anticipate that will happen about three months after approval.
Analysts expect sales of about $1 billion for Sage by 2029 and $1.2 billion for Biogen, which will receive half of US profits and has the rights to sell the drug in most international markets.
–With assistance from Shiyin Chen.
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