Staff and Wire Reports
Tuesday, 03 January 2012 08:05
Chelsea Therapeutics (Nasdaq:CHTP) has announced that FDA regulators have scheduled a meeting of the Cardiovascular and Renal Drugs Advisory Committee on February 23, 2012 to review the New Drug Application (NDA) for NORTHERA
- an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). NOH is a chronic neurogenic disorder resulting from deficient release of norepinephrine that predominantly affects patients with primary autonomic failure, a group of diseases which includes Parkinson's disease, multiple system atrophy and pure autonomic failure. Symptoms of NOH include: dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position, often severely limiting a person’s ability to perform routine daily activities that require standing or walking for both short and long periods of time.
Northera is the lead investigational agent in Chelsea Therapeutics' pipeline, has been studied in two Phase III clinical trials.
In November of 2011, the company announced that FDA officials had granted their request for Priority Review, and, under the Prescription Drug User Fee Act (PDUFA), the FDA's goal was to review and act on the NDA for Northera by March 28, 2012. Priority Review to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists.
The Cardiovascular and Renal Drugs Advisory Committee is an independent panel of experts that reviews and evaluates available data concerning the safety and effectiveness of products for use in the treatment of cardiovascular and renal disorders and makes appropriate recommendations to the FDA.
Chelsea Therapeutics is a biopharmaceutical company developing prescription products in multiple therapeutic categories such as RA, psoriasis and other inflammatory conditions. It was founded in 2002 as Aspen Therapeutics, Inc. and changed its name to Chelsea Therapeutics, Inc. in 2004. It was reincorporated as Chelsea Therapeutics International Ltd in July 2005.
Chelsea’s unique portfolio of novel antifolate compounds are engineered to treat a broad range of immunological disorders with fewer harmful and unpleasant side effects typically associated with classical antifolates. Its product portfolio includes: CH-1504, a product candidate that potently inhibits several key enzymes that are required for cell proliferation including dihydrofolate reductase (DHFR); Droxidopa, an orally active synthetic precursor of norepinephrine for the treatment of orthostatic hypotension; and I-3D portfolio, an extensive library of orally active therapeutic compounds that are indicated for potent inhibition of Dihydroorotate dehydrogenase (DHODH) activity while maintaining PK and safety properties superior to the marketed DHODH inhibitor during preclinical testing.
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