The Food and Drug Administration’s (FDA) cardiovascular and renal drugs advisory committee (CRDAC) voted 16-1 to recommend approval for Chelsea Therapeutics’ Northera (droxidopa) to treat symptomatic neurogenic orthostatic hypotension (nOH).
The drug will be for patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
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The FDA said it is not bound by the CRDAC’s recommendation, but will take it into consideration when reviewing the new drug application (NDA) for Northera.
According to the company, a prescription drug user fee act (PDUFA) action date for the Northera NDA has been scheduled for 14 February 2014.
Chelsea Therapeutics interim chief executive officer Joseph Oliveto said: "We are appreciative of the FDA bringing our Northera NDA before the cardiovascular and renal drugs advisory committee, and for the committee’s thoughtful discussion of the application."
The FDA had previously granted orphan drug designation to Northera for the treatment of rare diseases/disorders.
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By GlobalDataCurrently, Northera is in Phase III development for the treatment of symptomatic nOH in patients with primary autonomic failure, an indication that includes a significant number of patients with Parkinson’s disease, multiple system atrophy (MSA) and pure autonomic failure (PAF).
Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, increasing levels of NE in the nervous system, both centrally and peripherally. It received expanded Japanese marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients in 2000.
In the US and the EU, an estimated 300,000 patients suffer from chronic symptomatic nOH, caused by an underlying neurogenic disorder, such as Parkinson’s disease, MSA or PAF.
Dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes are the symptoms of nOH.
Image: PDUFA action date for Northera NDA has been scheduled for February 14, 2014. Photo: courtesy of freedigitalphotos.net.
