The company’s submission builds on findings from the CeleBrate study, which demonstrated that administering zalunfiban at the first point of medical contact effectively reduces severe heart damage. These results were previously presented at the American Heart Association Scientific Sessions and featured in The New England Journal of Medicine Evidence. Given its status as a novel small-molecule inhibitor of the platelet GPIIb/IIIa receptor, the drug is intended for subcutaneous injection in emergency settings where rapid intervention is critical for patient survival.
In section Releases
CeleCor Files FDA Application for Heart-Attack Treatment Zalunfiban
Del Mar-based CeleCor Therapeutics has finalized its New Drug Application with the U.S. Food and Drug Administration for zalunfiban, an investigational therapy designed to treat severe STEMI heart attacks. The filing follows a successful Phase 3 trial and the appointment of Michael Moye as the firm's new Chief Commercial Officer.
Regulators granted zalunfiban Fast Track status and a Rolling Review designation in January, a move that allows for an expedited evaluation process. Alongside the regulatory milestone, Michael Moye has joined the executive leadership team to spearhead commercial operations. Moye brings extensive experience from his previous roles at Idorsia, Shire, and Johnson & Johnson to support the potential launch of the drug.
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