FDA approves Chelsea's Northera

FDA granted accelerated approval to Northera droxidopa from Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) to treat neurogenic orthostatic hypotension (NOH). The label includes a boxed warning on the risk of increased blood pressure while lying down. Chelsea plans to launch the orally available synthetic precursor of norepinephrine next half but said it has not yet determined the price. The company said it was seeking accelerated approval of Northera and as part of post-marketing commitments will conduct a confirmatory placebo-controlled trial to establish the durability of the clinical benefits of the drug. Chelsea said it has yet to determine a start date for the trial, which is expected to enroll about 1,400 patients. ...