Dive Brief:

• Biogen and Sage Therapeutics will charge a sticker price of nearly $16,000 for a two-week course of their new postpartum depression drug Zurzuvae, the companies revealed Tuesday.

• Zurzuvae secured Food and Drug Administration approval as a postpartum depression treatment in August. But it couldn’t immediately enter the market, as it required scheduling from the Drug Enforcement Administration. The medicine works differently than available antidepressants, such as so-called SSRI drugs, and is only the second treatment to be cleared in the U.S. specifically for postpartum use.

• Biogen and Sage, which are jointly marketing Zurzuvae, expect to start selling it in December, with a more extensive commercial effort set to begin in early 2024.

Dive Insight:

Both Biogen and Sage have marked Zurzuvae as an important new product. Yet, in approving the therapy for postpartum depression, the FDA denied the companies’ request to also clear it for major depressive disorder, sharply limiting its market.

The decision was a blow to both companies, but especially Sage. The smaller biotechnology firm laid off 40% of its workforce and paused some early research in a restructuring announced a few weeks after Zurzuvae’s approval in postpartum depression, or PPD.

Sage expects the reorganization will save it approximately $240 million a year and help it launch Zurzuvae into a market that may take time to develop.

“Our goal is to make Zurzuvae available later this year and to enable broad and equitable access for women with PPD who are prescribed this drug,” said Sage CEO Barry Greene in a statement.

The $15,900 list price set by Sage and Biogen is below what some analysts had predicted, and significantly less than the $34,000 wholesale price for Sage’s postpartum depression infusion Zulresso, which won U.S. approval in 2019. (That drug has been little used, due in part to its 60-hour administration time.)

In a presentation Tuesday, Sage said it set the price based on Zurzuvae’s value proposition and the unmet need for effective postpartum depression treatment. The company and Biogen are “actively engaged” with insurers on coverage, Sage said.

Still, Zurzuvae’s launch may be slow to build, according to Paul Matteis, an analyst at the investment firm Stifel. In a note to clients Tuesday, he wrote that while psychiatrists appear positive about Zurzuvae, Sage will need obstetricians and gynecologists to prescribe the drug for it to become widely used.

About 1 in 8 women in the U.S. experience symptoms of postpartum depression following birth, according the companies. Many go undiagnosed, and those who are don’t always receive follow-up care.

Zurzuvae, which is given orally over 14 days, could help. In testing, antidepressive effects were reported as early as three days after the start of treatment. Trial results at 15 days post-treatment showed a significant improvement in depressive symptoms among participants on Zurzuvae, compare to those given a placebo.

The drug carries a “black box” warning recommending doctors instruct their patients not to drive a motor vehicle or engage in other complex tasks due to the drug’s depressant effects. The DEA has classified Zurzuvae as a “Schedule IV” drug, indicating a low potential for abuse and low risk of dependence.

Shares in Sage fell by 6% in Tuesday morning trading.