BioCentury
ARTICLE | Clinical News

Northera droxidopa regulatory update

July 22, 2013 7:00 AM UTC

Chelsea said FDA accepted for review a resubmitted NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The PDUFA date is Jan. 3, 2014.

Chelsea said the resubmission includes data from the Phase III Study 306B. In February, the company had announced that FDA said data from Study 306B may be sufficient as the basis of the resubmission. Chelsea said it may be required to verify the durability of effect of Northera in a postmarketing study, which is slated to begin in 4Q13. FDA had issued a complete response letter for Northera in March 2012 requesting data from an additional trial to show durability of effect over a 2-3 month period (see BioCentury, Feb. 25). ...