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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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Alkermes’ Antipsychotic Combo Faces US FDA Questions On Metabolic Effects, Opioid-Related Safety

ALKS 3831, which combines olanzapine with the mu opioid receptor antagonist samidorphan, was associated with less weight gain compared to olanzapine alone but showed no benefit on metabolic parameters; in advisory committee briefing documents, agency raises theoretical safety concerns about drug’s opioid antagonistic effects in real-world settings.

US FDA Has Soured On Abuse Deterrent Labeling Even Outside Of Opioids, Stimulant Docs Suggest

Arbor Pharmaceuticals’ ADHD drug faces a challenging advisory committee after FDA questions whether even an effective abuse-deterrent stimulant formulation could produce a public health benefit. And the agency isn’t convinced that Arbor’s 505(b)(2) application for its immediate release amphetamine formulation has in fact demonstrated it would reduce abuse and misuse.

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.

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