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FDA Advisory Panel Recommends Approval of Hypotension Drug Northera (Droxidopa)
Approval decision expected in February (January 14)
The FDA’s Cardiovascular and Renal Drugs Advisory Committee has voted 16 to 1 to recommend approval of Northera (droxidopa, Chelsea Therapeutics) for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson's disease [PD], multiple system atrophy [MSA], and pure autonomic failure [PAF]), dopamine beta hydroxylase deficiency, or nondiabetic autonomic neuropathy.
The FDA is not bound by the committee’s recommendation but will take it into consideration when reviewing the New Drug Application (NDA) for Northera. A Prescription Drug User Fee Act (PDUFA) action date has been scheduled for February 14, 2014.
Northera (droxidopa) is currently in phase III development for the treatment of symptomatic nOH in patients with primary autonomic failure — an indication that includes patients with PD, MSA, or PAF. Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.
Source: Chelsea Therapeutics; January 14, 2014.