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

 
• By Sue Sutter

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.

Whether the short-term benefit seen with Chelsea Therapeutics International Ltd.’s Northera (droxidopa) on the cardinal symptom of neurogenic orthostatic hypotension outweighs the lack of a demonstrated durable effect and questions about long-term safety is the issue facing FDA’s Cardiovascular and Renal Drugs Advisory Committee.

At the panel’s Feb. 23 review of droxidopa, the agency will also seek the committee’s views on whether the effect...

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