Ahead of FDA filing, Sage and Biogen tout more data in hopes of alleviating durability concerns

With an FDA filing rolling for zuranolone, Sage and Biogen are bringing more data on how the drug works in an open-label study.

The partners reported that out of patients with major depressive disorder who responded to the first round of treatment, the median time to another episode requiring repeat treatment was 135 days for those who got 30 mg of zuranolone and 249 days for those who got 50 mg. The data come as questions about the durability of zuranolone followed its two randomized trial readouts.

Sage and Biogen are painting their drug as a potential acute treatment for depression episodes, unlike drugs currently used for chronic maintenance.

The two companies previously reported the responder rate of the second group in the open-label study — 80% of nearly 200 patients responded to the 50 mg treatment. But they released only the non-responder rate for the 30mg cohort of 725…
Click here to view original post