Charlotte NC-based Chelsea Therapeutics (NASDAQ:CHTP
, Stock Forum
) has announced its Northera (droxidopa) product has won accelerated approval by the US Food and Drug Administration (FDA).
A decision regarding approval of the drug was postponed last Friday due to severe weather, but the stock was trade-halted Tuesday afternoon before the company announced the news.
According to the company, “NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the ‘feeling that you are about to black out’ in adult patients with symptomatic NOH caused by primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.”
“The approval of NORTHERA is an extraordinary achievement, one for which I thank patients and their families, investigators and the medical community, our partner Dainippon Sumitomo, and our employees,” said Joseph G. Oliveto, President and Chief Executive Officer of Chelsea Therapeutics. “We will now turn our efforts towards delivering NORTHERA to patients with NOH in the United States, an important goal we expect to achieve in the second half of the year.”
The accelerated approval program allows for ‘conditional approval of a medicine that fills a serious unmet medical need, provided additional confirmatory studies are conducted’, according to the company.