Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape
Phase III Data Seen As Underwhelming
The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption
You may also be interested in...
Praxis Moves Away From Depression With Surprising Phase II/III Failure
With GABA-A modulator PRAX-114 missing all endpoints in a monotherapy study, Praxis will cease development of that drug and focus on its candidates for essential tremor and epilepsy.
Sage/Biogen Zuranolone Study Shows More Efficacy, But Higher Toxicity
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.
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.