Sage/Biogen Delay Zuralone Filing, Commercial Path Remains Unclear
The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.
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The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption
Rather than hitting the acquisition trail, Biogen has taken the licensing route to expand its psychiatric and neurological disorders pipeline.
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.