US pharmaceutical company CeleCor Therapeutics said on Wednesday that it has submitted the final section of its New Drug Application (NDA) for the company's investigational heart-attack drug, zalunfiban (Disaggpro), to the US Food and Drug Administration (FDA).

The NDA filing follows presentation in November of positive Phase 3 results from CeleCor's CeleBrate study at the American Heart Association Scientific Sessions, as well as publication of the results in The New England Journal of Medicine Evidence.

Zalunfiban has FDA Fast Track status and was granted Rolling Review in January. This allows submission of documents and data as they become available, enabling regulators to begin their review early and creating the potential to shorten the review timeline.

According to Celacor, the multinational CeleBrate study found that rapid zalunfiban treatment for STEMI heart attacks at first point of medical contact lowered risk of more severe heart damage in combination with other serious heart-attack complications. STEMI (ST-segment elevation) heart attacks are the most severe form of heart attack; the priority in treating them is opening the coronary artery as soon as possible to prevent death or irreversible heart damage.