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

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

Source: 
Endpoints
snippet: 

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.