Chelsea Therapeutics Northera for Dizziness Wins Backing of FDA Panel
Chelsea Therapeutics International Ltd. (CHTP) surged the most in almost seven years after the company’s drug to treat a condition that can cause dizziness in people with central nervous system disorders won the backing of a U.S. advisory panel.
Chelsea Therapeutics climbed 61 percent to $3.88 at the close in New York, its biggest increase since June 2005. Shares of the Charlotte, North Carolina-based company had fallen 41 percent in the 12 months before today.
The panel voted 7-4 yesterday in Silver Spring, Maryland, that the treatment called Northera, potentially the company’s first on the market, should be approved. The Food and Drug Administration is scheduled to decide whether to clear the drug for sale by March 28. The agency doesn’t have to follow the panel’s recommendation.
A Feb. 21 report by FDA reviewer Melanie Blank said Northera, chemically known as droxidopa, shouldn’t be approved because it may be linked to a life-threatening neurological disorder and wasn’t proven to work long-term. Panel members who voted in favor of the drug said the benefits outweigh the risks because there are few treatments for the debilitating disease.
“I believe this is a very difficult disease,” Michael Lincoff, chairman of the panel and a professor of medicine at the Cleveland Clinic, said during the meeting. “In the end there is no question in my mind this drug is efficacious in a subset of patients and the risks are not unpredictable, they’re treatable.”
About 180,000 patients in the U.S. suffer from the blood pressure drop Northera aims to treat known as neurogenic orthostatic hypotension, Keith Schmidt, vice president of sales and marketing for Chelsea Therapeutics, said on Nov. 2 during a call with analysts. Patients can become dizzy and even faint.
Available in Japan
Northera is available in Japan as part of a marketing agreement with Dainippon Sumitomo Pharma (4506) Co. and generates annual revenue of $50 million, Chelsea Therapeutics said on its website. The FDA is concerned that the drug has been associated with 28 reports of a life-threatening neurological disorder known as neuroleptic malignant syndrome in patients in Japan, the agency’s Blank told the panel. The reports don’t contain enough detail to determine whether the condition is related to the drug, she said.
No incidents of the disorder have been reported in the company’s studies, Chelsea Therapeutics said in a Feb. 13 statement.
In addition, 19 deaths occurred in Chelsea Therapeutic- sponsored trials on Northera, nine of which may plausibly be associated with the drug, FDA reviewer Blank told the panel.
The Japanese data should be discounted because the country’s health system is different and because the reports aren’t detailed, panel member Julia Lewis, professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee, said during the meeting.
The company’s first trial examining Northera failed to show the drug worked, according to the FDA staff report. Chelsea Therapeutics then changed the endpoint that would measure success of another trial, which determined the treatment was effective. The endpoint changed from one set of questions asking patients about their ability to stand and walk to another set assessing a wider range of symptoms. The medicine would have shown same results even if Chelsea Therapeutics stuck with the first endpoint, the staff report said.
A third, longer trial failed to show a difference between patients who took Northera and those that took a placebo after three months with a two-week withdraw period, suggesting positive effects of the drug may wear off, the staff report said.
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