Chelsea Therapeutics International Ltd. won U.S. approval for its drug to prevent sudden drops in blood pressure, the company’s first product to reach the market.
The medicine, called Northera, was cleared for sale to prevent patients with nervous system disorders from the blood pressure crash that can lead to dizziness and fainting, the Food and Drug Administration said today in a statement. The FDA rejected Charlotte, North Carolina-based Chelsea’s first attempt to gain approval for Northera in March 2012 for the condition called neurogenic orthostatic hypotension.
The therapy may generate $450 million in peak U.S. sales, Robyn Karnauskas, an analyst with Deutsche Bank AG, said Feb. 14 in a note to clients. A panel of agency advisers voted overwhelmingly last month to recommend Northera’s approval. FDA staff members had expressed concern that Chelsea hadn’t proved the drug works longer than a week while advisers pushed for flexibility because no other treatments exist for the condition.
“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research, said in the statement. “There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available.”
Neurogenic orthostatic hypotension affects as many as 300,000 people in the U.S. and Europe who typically have illnesses such as Parkinson’s disease, according to Chelsea. When taken, Northera is converted into the hormone norepinephrine, which increases blood pressure.
Northera will carry a boxed warning about the risk of increased blood pressure while lying down, which can lead to stroke, the FDA said. Patients must sleep with their upper bodies elevated, the agency said.
The drug was cleared under the FDA’s accelerated approval program, which will require Chelsea to prove the medicine works to relieve dizziness over the long term. The most common side effects reported by patients taking Northera in clinical trials were headache, dizziness, nausea, high blood pressure and fatigue.
Northera will be available for patients in the second half of the year, Chelsea said in a statement.