Northera droxidopa regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 7-4, with one abstention and one non-vote, to recommend approval of Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH). The positive vote came after agency briefing documents recommended against approval of the orally available synthetic precursor of norepinephrine.

While acknowledging concerns about the limited duration of efficacy data and a lack of long-term safety data, most panel members concluded the available evidence of efficacy was sufficient to outweigh the questions, particularly in light of the serious unmet medical need of NOH patients. "There is no question this drug is efficacious," noted A. Michael Lincoff, the committee chair. "The risks are not unpredictable, measurable and treatable." Lincoff is a cardiologist at the Cleveland Clinic. ...