Sage's Regulatory Strategy For Zuranolone Remains Uncertain
The company said it will update investors on the path forward for zuranolone in major depressive disorder after finalizing discussions with the US FDA. It would not confirm if a meeting had taken place yet.
You may also be interested in...
Sage will initiate three new trials to support FDA approval of the drug for post-partum depression and major depressive disorder, with data anticipated in 2021.
Sage Therapeutics points to patient compliance and selection as factors in its failed trial of SAGE-217. The company sees positive implications in the data as it waits for other SAGE-217 studies.
I.V. Zulresso is the first US FDA-approved drug for postpartum depression (PPD) and Sage's first commercial product – with a list price of $34,000. It will help the company build a presence in PPD as it completes late-stage development for oral candidate SAGE-217.