Shares in Chelsea Therapeutics have smashed through the roof after FDA advisors turned out an almost unanimous thumbs up for its blood pressure drug Northera (droxidopa).
The group's stock is currently up 120% (pre-market) as investors revel in news that the drug, an orally active synthetic precursor of norepinephrine which was turned down by the regulator in 2012, is now well on track for imminent approval.
The Agency's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend a green light for Northera for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, a group of diseases which includes Parkinson's disease, multiple system atrophy and pure autonomic failure.
NOH is a chronic neurogenic disorder caused by a deficient release of norepinephrine, which can give rise to symptoms such as 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.
Early 2012 the FDA rejected Northera, which carries Orphan Drug status, for NOH, asking Chelsea for more data on its filing despite its CRDAC having voted 7-4 in favour of the therapy at the time.
Northera's resubmitted New Drug Application was subsequently accepted for review last September, with a new Prescription Drug User Fee Act goal date of February 14, 2014.