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
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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.
After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.
The first disease modifying drug for Alzheimer's disease will be priced at a $56,000 a year for an average weight patient, setting the drug up to be a mega blockbuster if Biogen can get it reimbursed.