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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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.
The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption
Before pivotal depression data in 2021 attempt to redeem zuranolone after a failed Phase III study, the company will report Phase II results for next-gen GABA modulator SAGE-324 in essential tremor.