FDA approves Northera for neurogenic orthostatic hypotension

Shares of US biotech firm Chelsea Therapeutics (Nasdaq: CHTP) soared 38% to $6.75 in after-hours trading yesterday, when the US Food and Drug Administration approved the company’s Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). Share trading was suspended ahead of the FDA decision.

NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands. Northera received orphan-product designation from the FDA because it is intended to treat a rare disease or condition.

“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available,” he noted.

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