Chelsea Therapeutics says FDA allows Northera resubmission with existing data
Feb 20 (Reuters) - Chelsea Therapeutics International Ltd said U.S. health regulators have informed the company that it may reapply for the marketing approval of its once-rejected hypotension drug Northera using data from its earlier study.
Chelsea's shares more than doubled in value to $1.61 before the bell on Wednesday, as the company said it plans to file for approval for the drug in the second quarter of the year.
The U.S. Food and Drug Administration had rejected Northera last March and asked Chelsea to conduct another clinical trial to show the drug was effective over a longer period.
FDA's guidance was in response to a formal appeal by Chelsea to the Director of the Office of New Drugs of the FDA, Chelsea said in a statement.
"We now have a regulatory path forward, including the potential for an approval of Northera later this year," Chelsea's interim Chief Executive Joseph Oliveto said.
In August, Chelsea changed the main goal of its earlier study, codenamed 306B, and re-reported results in December showing Northera significantly reduced dizziness in patients at week one, but results beyond that period were not statistically significant.
Chelsea said on Wednesday that the FDA guidance suggests data from its completed 306B study strongly show a short-term clinical benefit, but there was a possibility the regulator would need a post-approval study to verify the drug's long-term clinical benefit.
The company said it plans to start a new clinical trial in the fourth quarter of the year to test for long-term benefits of the drug.
Northera is aimed at treating symptomatic neurogenic orthostatic hypotension, or a chronic drop in blood pressure on standing up that is most often associated with Parkinson's disease.