CeleCor Therapeutics has completed its New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) for investigational heart attack treatment zalunfiban following positive Phase III study results.

• Product Details: Zalunfiban is an investigational small-molecule inhibitor of the platelet GPIIb/IIIa receptor designed for subcutaneous injection at the first point of medical contact before patients reach a catheterisation laboratory.
• Clinical Trial: The multinational Phase III CeleBrate study found that rapid administration of zalunfiban at first medical contact reduced the risk of more severe heart damage together with other serious heart attack complications.
• Regulatory Status: Zalunfiban has FDA Fast Track status and was granted Rolling Review, allowing sections of the NDA to be submitted as they became available.

This summary is based on a news report published by BioSpectrum Asia.

Image for illustrative purposes only. Source: Canva.

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