- Sage Therapeutics and Biogen intend to, over the next roughly year and a half, submit an experimental drug called zuranolone for approval in two types of depression, the companies announced Tuesday.
- The plan is to ask the Food and Drug Administration to first clear zuranolone for the treatment of major depressive disorder, then file a separate application to get it approved for postpartum depression. The companies expect to complete these filings in the second half of 2022 and the first half of 2023, respectively.
- In a statement, the companies said recent discussions with the FDA, including a meeting this fall, helped shape their decision to submit zuranolone for approval. The drug has a mixed track record in clinical testing, but Biogen and Sage believe they have enough positive data to warrant approvals.
Zuranolone is an important asset to both of its backers. Mid-stage clinical studies suggested the drug, which was designed to work differently than typical antidepressants, could be a useful new treatment option for multiple kinds of depression. And though it has run into obstacles — most notably, failing a key late-stage study in major depressive disorder — Wall Street analysts still expect peak sales of at least $1 billion.
For Sage, a sales boost of that size would be significant. The company sells one product, Zulresso, the first medicine ever approved by the FDA for postpartum depression. But the complicated way in which its given to patients has limited it commercially. Last year, Sage recorded just $6.7 million in Zulresso revenue.
A zuranolone approval might also return some investor confidence in Sage, which has watched its share price sink by more than half since the start of the year. As of Tuesday morning, shares were trading at around $42 apiece, down 5% from the day prior and well off the $183 they went for in the summer of 2019, right before that major depressive disorder study produced negative results.
In the aftermath of the failed study, Sage redrew its development plans for zuranolone. It launched three short studies to test the drug against postpartum depression or major depressive disorder, with the hope that positive results from any could provide enough evidence to warrant an approval application. This June, the company released results from one of major depressive disorder trials, known as WATERFALL, and though still mixed, they showed zuranolone hit the trial's main goal.
Sage's other major depressive disorder study, named CORAL, is fully enrolled and should produce high-level data in early 2022. The postpartum depression study, called SKYLARK, is still recruiting, but is expected to wrap up next September.
Analysts have argued the CORAL results will be crucial to getting investors and doctors on board with zuranolone. RBC Capital Markets, for instance, recently surveyed 30 psychiatrists, and though they generally viewed the drug as slightly more effective than other agents, some had concerns about safety and tolerance. In WATERFALL, zuranolone treatment was associated with higher rates of side effects like drowsiness and sedation.
"We believe this indicates how important it might be for [Sage and Biogen] to clearly articulate zuranolone's tolerability profile ... to clinicians," wrote RBC analyst Brian Abrahams in a June 28 note.
As for Biogen, which shelled out $1.5 billion to gain rights to zuranolone, an approval would help to validate its deal with Sage.
Additionally, Biogen is facing several major challenges, including competition in its core research areas of multiple sclerosis and spinal muscular atrophy. The company's controversial new Alzheimer's disease drug, meanwhile, has run into significant commercial obstacles, threatening the high sales expectations that were previously set for it.
Sage and Biogen said they are submitting the approval applications for major depressive disorder and postpartum depression separately, so that the SKYLARK study doesn't affect the timeline for a verdict in major depressive disorder.
The companies noted, though, the review cycles may allow them to simultaneously commercialize zuranolone for both diseases, if approved.