Northera droxidopa regulatory update

Chelsea said FDA will delay the 6-month PDUFA review period for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) until the biotech addresses technical deficiencies identified in a resubmitted NDA. Chelsea said it expects to submit a response this month. In July, the agency accepted the resubmitted NDA and assigned the application a Jan. 3, 2014, PDUFA date (see BioCentury, July 22). Chelsea said FDA noted deficiencies related to the formatting of submitted electronic datasets and statistical programs describing the methods used to generate tables and listings. The application is seeking approval of Northera to treat symptomatic NOH in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

The resubmission included 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 (see BioCentury, Feb. 25). 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, April 2, 2012). ...