Northera Survives Questions About Benefit Of Dizziness Endpoint At Advisory Panel
This article was originally published in The Pink Sheet Daily
The Cardiovascular and Renal Drugs Advisory Committee Jan. 14 supported approval of the drug for symptomatic neurogenic orthostatic hypotension on a vote of 16-1.
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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.
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.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.