Surprise FDA advisory panel backing for Chelsea’s Northera

A US Food and Drug Administration advisory panel has voted 16-one to recommend approval of US biotech firm Chelsea Therapeutics’ (Nasdaq: CHTP) Northera (droxidopa), causing the company’s shares to leap 10.9% to $2.55 in after-hours trading yesterday.

Northera is backed by the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

Positive vote despite previous FDA rejection