Chelsea Vows To Resolve Latest Regulatory Woes With Northera Quickly
This article was originally published in The Pink Sheet Daily
Technical deficiencies foil the resubmission of Chelsea Therapeutics’ Northera. The company thinks it can resolve the problems quickly and some analysts expect a relatively short delay of one or two months to the user fee date.
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The company says a data formatting issue was the reason FDA declined to accept the supplemental application for alemtuzumab for relapsing multiple sclerosis.
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.
Chelsea Therapeutics’ development program for droxidopa in neurogenic orthostatic hypotension led to discussion at a recent advisory committee meeting about the role of Special Protocol Assessments and appropriate validation of patient-reported outcome instruments.