Northera Ongoing Trial May Satisfy FDA Request For More Efficacy Data, Chelsea Says
This article was originally published in The Pink Sheet Daily
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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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.
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.
Chelsea would address duration of effect questions for the neurogenic orthostatic hypotension drug with a post-approval study.