Shares in Chelsea Therapeutics International have leapt after the company said it will resubmit its previously-rejected treatment of neurogenic orthostatic hypotension, Northera, after helpful discussions with US regulators.
A year ago, the Food and Drug Administration issued Chelsea with a complete response letter asking for more data regarding its filing for Northera (droxidopa) for NOH. That came as something of a surprise given that the agency’s Cardiovascular and Renal Drugs Advisory Committee had earlier voted 7-4 in favour of the therapy.
Now Chelsea says that following a meeting, it has received written guidance from the Director of the Office of New Drugs at the FDA stating that an ongoing study has the potential to serve as the basis for a resubmission.
The guidance suggests that “data strongly demonstrating a short-term clinical benefit of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval”.
Encouraged by this, Chelsea plans to refile Northera in the late second quarter of 2013. Chief executive Joseph Oliveto said the firm looks forward to submitting the totality of our clinical experience to date to the agency for review…we now have a regulatory path forward”.
Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013.
