Northera Survives Questions About Benefit Of Dizziness Endpoint At Advisory Panel

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.

Members of the Cardiovascular and Renal Drugs Advisory Committee accepted improvement in dizziness is a reasonable endpoint for measuring a drug’s benefit in treating symptomatic neurogenic orthostatic hypotension Jan. 14 as they voted 16-7 in favor of approving Chelsea Therapeutics International Ltd.’s Northera (droxidopa) for NOH.

Dizziness “is kind of the core patient-oriented measure” of what matters to those with the disease, noted Vanessa Hinson, Medical...

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