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FDA panel backs Chelsea's Northera for rare disease

Committee votes in favour of treatment for low blood pressure
FDA headquarters White Oak

A US Food and Drug Administration (FDA) panel has backed the use of Chelsea Therapeutics' Northera for use in the treatment of a rare low blood pressure condition.

The regulator's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16 to 1 in favour of the approval of Northera (droxidopa) to treat symptomatic neurogenic orthostatic hypotension (nOH) in patients with an underlying neurogenic disorder, such as Parkinson's diseases or multiple system atrophy.

Symptomatic nOH is a chornic condition that leaves patients with low blood pressure and related dizziness, light-headedness, blurred vision, fatigue and other symptoms.

According to Chelsea, these effects can “severely limit a person's ability to perform routine daily activities that require standing or walking for both short and long periods of time”.

The FDA previously granted orphan drug status to Northera due to the rareness of the condition, which is thought to affect about 300,000 people in the US and EU combined.

The designation offers incentives, such as tax credits, to companies manufacturing drugs for rare diseases.

The FDA will now make a final decision on whether to approve Northera by February 14.

Article by
Thomas Meek

15th January 2014

From: Sales



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