A review, posted on the FDA's website on Friday,
comes ahead of a meeting on Jan. 14 of outside medical experts
who will discuss the drug and recommend whether it should be
approved. The FDA generally follows the advice of its advisory
The drug, droxidopa, is designed to treat neurogenic orthostatic
hypotension (NOH), a rare, chronic type of low blood pressure that
occurs on standing.
Arguments in favor of approval include "strong evidence" that the
drug confers at least one week of benefit, the staff review found.
Arguments against approval include a lack of evidence that the
benefit is durable over a longer period of time.
The disorder is associated with certain neurological disorders such
as Parkinson's disease; multiple system atrophy; and pure autonomic
failure — conditions which can impair the body's involuntary
functions such as blood pressure and heart rate.
(Reporting by Toni Clarke in Washington)
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