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

This article was originally published in The Pink Sheet Daily

Executive Summary

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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Durability Questions Mean Northera Should Be Limited To Short-Term Use, Panel Says

The durability of treatment effect for Chelsea’s NOH drug is an issue for a post-marketing study to answer, FDA’s Cardiovascular and Renal Drugs Advisory Committee said in recommending approval on a 16-1 vote.

Data Limitations Continue To Plague Northera As The NOH Therapy Goes To Its Second Advisory Committee

FDA will ask the Cardiovascular and Renal Drugs Advisory Committee Jan. 14 whether there is a population that showed a better than mean effect for the primary endpoint of dizziness.

Northera Ongoing Trial May Satisfy FDA Request For More Efficacy Data, Chelsea Says

In a “complete response” letter to Chelsea for use of droxidopa in treating neurogenic orthostatic hypotension, FDA requests data from an additional trial showing efficacy and durability of effect. Chelsea believes ongoing Study 306, which has had its own efficacy challenges, could fill the bill and enable an NDA resubmission as early as the first quarter of 2013.

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