FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' NORTHERA(TM) (Droxidopa) for the Treatment of Symptomatic nOH

Chelsea Therapeutics International

today announced that the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA™ (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The FDA is not bound by the CRDAC'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 for the Northera NDA has been scheduled for February 14, 2014. "Chelsea is committed to improving the lives of patients with nOH, a debilitating disorder which often severely limits a person's ability to perform routine daily activities," said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea Therapeutics. "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." Northera was previously granted Orphan Drug Designation, which is granted by the FDA to treatments for rare diseases/disorders. About Symptomatic nOH It is estimated that nearly 300,000 patients suffer from chronic symptomatic nOH in the U.S. and EU combined. Symptomatic nOH is a chronic disorder that is caused by an underlying neurogenic disorder, such as Parkinson's disease, multiple system atrophy or pure autonomic failure. Symptoms of nOH include dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position. These symptoms often severely limit a person's ability to perform routine daily activities that require standing or walking for both short and long periods of time. About Northera NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (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, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.