Northera droxidopa regulatory update
FDA granted accelerated approval to Northera droxidopa from Chelsea to treat neurogenic orthostatic hypotension (NOH). Specifically, the drug is indicated to treat orthostatic dizziness, lightheadedness or the "feeling that you are about to black out" in adult patients with symptomatic NOH caused by primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. 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 postmarketing 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. ...