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

Executive Summary

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.

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Chelsea’s Northera Clears FDA But With A Confirmatory Trial Requirement

Northera was approved by FDA under the Subpart H accelerated approval pathway; the Indications and Usage section of the drug’s labeling notes the lack of efficacy data for treatment with the drug beyond two weeks.

Chelsea’s Northera Plan: Expand Ongoing Study While Assuring Integrity Of Older Data

Chelsea said it will address FDA’s “complete response” letter by modifying and enlarging an ongoing droxidopa clinical trial and submitting all patient source documentation from an ex-U.S. study site in the completed pivotal trial that the agency has called into question.

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

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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