After scoring limited FDA nod, Sage and Biogen call an audible on pricing strategy for Zurzuvae

Before Sage and Biogen’s Zurzuvae (zuranolone) won approval from the FDA for postpartum depression (PPD) in August, the companies had said that the highly anticipated first-in-class treatment would be available for less than $10,000.

But the companies’ failure to win over regulators for Zurzuvae to treat a significantly larger patient population—major depressive disorder (MDD)—threw their pricing strategy out the window.

On Tuesday, as it presented its third-quarter earnings, Massachusetts-based Sage revealed that it will charge $15,900 for a full course of the treatment, which is taken orally for 14 days.

When asked on a conference call what Zurzuvae’s price would have been if the drug was also approved for MSS, Sage CEO Barry Greene didn’t address the question. But he did characterize the price tag as a bargain, citing a 2017 report that concluded the average societal cost per woman with PPD was $32,300.

“We believe that with the wholesale acquisition cost, we are providing value to the healthcare system,” Green said. “If another indication comes back on the table later, we’ll make those adjustments.”

Zurzuvae is the first pill in the United States approved specifically for the PPD indication. The company said it plans to launch the treatment in December. 

Failing to win approval to treat MDD threw the company into a tailspin, forcing a reorganization which lopped 40% of its workforce, including three C-suite execs.

The shifts will result in savings of $240 million, chief financial officer Kimi Iguchi said, with $100 million related to the layoffs.

“While we’re thinking big about the launch opportunity in this indication, we are going to start with a focused approach and scale fast as we see success,” Iguchi said.

The company still believes Zurzuvae has “blockbuster potential,” Greene said. But that level of sales will take a while as PPD remains an under-diagnosed condition.

When the FDA came up with its split decision on Zurzuvae, analysts pointed out that MDD would have offered a “meaningfully larger opportunity,” with projected 2030 sales of about $1.3 billion. That compares with roughly $200 million for PPD.

This is not the first PPD drug marketed by Sage. In 2019 the company gained an FDA thumbs up for infused Zulresso but the treatment has languished because of its $34,000 price tag and lengthy administration, which takes 60 hours. The drug generated just $2.7 million in revenue in the third quarter, the company reported.