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Orphan Disease Setting Drives FDA Panel Endorsement Of Chelsea’s Northera

This article was originally published in The Pink Sheet Daily

Executive Summary

Seven of 13 members of the Cardiovascular and Renal Drugs Advisory Committee supported approval for treatment of symptomatic neurogenic orthostatic hypotension. Those voting in favor cited lack of few effective therapies and patient testimony of dramatic quality-of-life improvements. Dissenters cited need for more long-term safety and efficacy data.

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FDA Panel Will Weigh Northera’s Short-Term Benefit Vs. Lack Of Durable Effect, Safety Concerns

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