Chelsea Therapeutics International Ltd.'s drug to treat debilitating drop in blood pressure has won approval from the U.S. Food and Drug Administration on Tuesday, Bloomberg News reported.
The medicine, called Northera, was approved for the treatment of neurogenic orthostatic hypertension, 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.
"The approval of Northera is an extraordinary achievement, one for which I thank patients and their families, investigators and the medical community, our partner Dainippon Sumitomo, and our employees", Joseph Oliveto, president and CEO of Chelsea Therapeutics, said in a statement.
The Northera is now the first FDA-backed drug for this condition, PMLive reported.
"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 a statement. "There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available."
Northera was approved under the accelerated approval program which allows for approval of a drug to treat a serious disease based on clinical data showing the drug has an effect on an intermediate clinical measure "that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment)," FDA officials said in a statement.
The effectiveness of Northera was shown through two-weeks in two clinical trials in people with neurogenic orthostatic hypertension.
People taking Northera reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if they might black out compared to those taking an inactive pill (placebo).
The most common adverse events reported by clinical trial participants taking Northera were headache, dizziness, nausea, high blood pressure (hypertension) and fatigue.
"Durability of the improvement in patient symptoms beyond two weeks has not been demonstrated," FDA official said.
