Sage/Biogen Zuranolone Study Shows More Efficacy, But Higher Toxicity
Commercial Prospects Still Murky
Data from SHORELINE’s 50mg cohort sparked mixed opinions from analysts, with some suggesting they still showed a risk-benefit profile that could challenge the drug commercially.
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Lecanemab is now filed for accelerated approval with the US FDA, but the wait for a Phase III readout could impact the hunt for Biogen’s next CEO.
Data from the Phase III CORAL study of zuranolone showed the drug missing efficacy at day 15, which may dampen its appeal in the real-world setting.
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.