Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH).
The company is seeking approval to market the orally active synthetic precursor of norepinephrine, Northera, for the treatment of symptomatic NOH in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
Chelsea interim chief executive officer Joseph Oliveto said the FDA acknowledgement of the completeness of NDA resubmission is another key milestone in reaching the goal.
"We will continue to work closely with the FDA toward an approval decision for Northera by early next year, and advance our commercial strategy in anticipation of a U.S. commercial launch soon after this," Oliveto added.
Earlier, Northera that is currently in Phase III development for the treatment of symptomatic NOH in patients with primary autonomic failure obtained orphan drug designation and fast track designation from the FDA.
Droxidopa was originally developed by and licensed from Dainippon Sumitomo Pharma.
