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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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Biogen's Aducanumab Advisory Committee Will Test US FDA's 'Substantial Evidence' Flexibility

Given inconsistent study results, robustness of the efficacy evidence is expected to be key focus of the 6 November meeting of the Peripheral and Central Nervous System Drugs Advisory Committee; review could put a December 2019 guidance on the ‘substantial evidence’ standard to the test and offer insight into the amount of flexibility the agency is willing to exercise for neurodegenerative diseases with high unmet need.

COVID-19 Vaccine Advisory Committee May Help Determine US FDA Approach To Licensure

The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.

First Phase III Depression Data For Intra-Cellular’s Caplyta Exceed Expectations

With positive results from the first Phase III trial of lumateperone in major depressive disorder and a second readout expected later this quarter, the company plans a supplemental filing in late 2024.

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