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Chimerix Receives Orphan Drug Designation from the FDA

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H8ster   Friday, 06/08/18 05:32:09 PM
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Chimerix Receives Orphan Drug Designation from the FDA for Brincidofovir for the Treatment of Smallpox

Chimerix (CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for brincidofovir for the treatment of smallpox.

Chimerix has been working with the Biomedical Advanced Research and Development Authority (BARDA) since 2011 to develop brincidofovir as a medical countermeasure for smallpox, demonstrating improved survival rates following confirmed orthopoxvirus infections in multiple animal models.

“We are very pleased to have received Orphan Drug Designation from the FDA for brincidofovir as a treatment for smallpox,” said M. Michelle Berrey, MD, MPH, President and Chief Executive Officer of Chimerix. “Though declared eradicated in the late 1970s, smallpox, whether natural or synthetic, continues to be a potential global threat in today’s interconnected world. We are committed to completing the development program for brincidofovir as a much-needed treatment option for smallpox, in close collaboration with BARDA and FDA.”

Orphan Drug Designation

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