Sage/Biogen Delay Zuranolone 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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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 company reported $1m in Q4 sales of its Alzheimer’s drug. Biogen expects Aduhelm to make a minimal contribution to full-year 2022 revenues, which will total about $1bn less than in 2021.
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.