Chelsea Thera to re-file Northera NDA with existing data; Celgene share buyback

Chelsea Therapeutics International (Nasdaq: CHTP) saw its shares more than double to $1.61 in pre-market trading yesterday, as the company announced that it has received written guidance from the Director of the Office of New Drugs the US Food and Drug Administration, stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera (droxidopa) New Drug Application for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).

The guidance is in response to a formal appeal by Chelsea to the Director, after the FDA last year said that Study 306B is unlikely to provide sufficient confirmatory evidence to support a Northera capsules NDA (The Pharma Letter July 4, 2012) and follows a meeting with the Director and top staff from the Office of Drug Evaluation I and Division of Cardiovascular and Renal Products (DCRP) at the FDA's Center for Drug Evaluation and Research.

The guidance suggests that "data strongly demonstrating a short-term clinical benefit (eg, improvement in symptoms or ability to function) of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval." It further notes that any decision regarding the outcome of an FDA review, to be performed by the DCRP will be based on the strength of Study 306B and its ability to provide substantial evidence of effectiveness to support approval.