Orphan Disease Setting Drives FDA Panel Endorsement Of Chelsea’s Northera
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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At its Feb. 23 review of Chelsea Therapeutics’ investigational orthostatic hypotension drug droxidopa, FDA’s Cardiovascular and Renal Drugs Advisory Committee will be asked to discuss sufficiency of the short-term efficacy data, clinical meaningfulness of the effect size and safety issues, including Japanese post-marketing reports of neuroleptic malignant syndrome.
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