Dow Jones Newswires
(2/24, Tadena, Subscription Publication) reports an advisory panel for
the US Food and Drug Administration has recommended approval of a drug
called droxidopa [Northera], used to treat symptomatic neurogenic
orthostatic hypotension.
Bloomberg News
(2/24, Edney) reports the medication is made by Chelsea Therapeutics
International Ltd., and is intended "to treat a condition that can cause
dizziness in people with central nervous system disorders." The
reviewers "voted 7-4 today in Silver Spring, Maryland, the treatment
called Northera, potentially the company's first on the market, should
be approved." The agency "is scheduled to decide whether to clear the
drug for sale by March 28."
"An FDA staff review released before the meeting had recommended against
approval, citing lack of evidence that the drug is effective for longer
than four weeks and 'worrisome safety signals' seen in clinical
trials," MedPage Today
(2/24, Gever) adds. "Chelsea's marketing application was based largely
on two randomized trials and an open-label extension to one of them."
Though "one of the randomized studies failed to meet its
primary efficacy endpoint, which the FDA staff review noted among the
drug's negatives." Also covering the story is Reuters (2/24, Morgan).
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