Outlook For Biogen's Aducanumab Brightens Based On FDA Clues
Biogen's stock soared 44% after the US FDA released briefing documents for a high-profile advisory committee meeting to review aducanumab for Alzheimer's disease.
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Aduhelm Observational Study Will Spur Debate On Utility of Real-World Evidence For mABs In Alzheimer’s
Biogen’s ICARE AD-US study will assess the effects of aducanumab prescribed in routine practice to 6,000 patients. The lack of a concurrent control arm has critics questioning the study’s utility, but others say it could provide useful data on patient subgroups who were underrepresented or excluded from clinical trials and inform as to ARIA risks.
Even analysts who still doubt the FDA will approve the anti-amyloid antibody as the first disease-modifying Alzheimer’s treatment said aducanumab’s likelihood of approval has improved.
The (virtual) doors closing on the J.P. Morgan Healthcare Conference is the sign for the biopharma industry that the new year has truly started, but before we get too far into 2021, Scrip has taken a look at five of the biggest non-COVID-19 story themes of 2020 in no particular order.