Chelsea Therapeutics, Inc. Expects to Resubmit Northera for FDA Approval in 2nd Quarter
Published: Feb 21, 2013
Chelsea Therapeutics International Ltd plans to repitch its once-rejected hypotension drug Northera in the second quarter after a review by U.S. health regulators determined that the company could use its original data for the resubmission. Shares of Chelsea were up 93 percent at $1.48 in heavy volume trading on Wednesday on the Nasdaq. The stock traded around the $4 levels before the FDA rejection. "(Wednesday's news) was surprisingly positive given what the FDA reviewers earlier said," Liana Moussatos of Wedbush Securities said. The FDA's guidance was in response to a formal appeal by the company to the Director of the Office of New Drugs of the FDA, after the Cardiovascular and Renal Products committee denied approval to the drug last March, asking for another study to show long-term benefit. This means the FDA believes the data Chelsea had submitted last year for approval can serve as the basis for a resubmission of the marketing application of Northera, analyst Moussatos said. Northera is being tested for symptomatic neurogenic orthostatic hypotension, or a chronic drop in blood pressure on standing up that is most often associated with Parkinson's disease. The drug has an orphan drug status, or a seven-year marketing exclusivity from the day of approval. "We now have a regulatory path forward, including the potential for an approval of Northera later this year," said Chelsea's interim Chief Executive Joseph Oliveto. However, risks still remain as the Cardiovascular and Renal Products committee of the FDA, which rejected the drug last year, will be the one reviewing it after Chelsea resubmits its application, Moussatos added.