Chelsea Therapeutics
International CHTP 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.
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