Pulmocide Ltd. (“the Company”), a late-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for patients with severe pulmonary diseases, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug, Fast Track and Qualified Infectious Disease Product designations for opelconazole (PC945) for the treatment of invasive pulmonary aspergillosis (IPA).
Orphan Drug designation provides companies with regulatory and financial incentives to develop and market medicines intended to treat, prevent or diagnose life-threatening or chronically debilitating rare diseases. Fast Track designation is an FDA process designed to facilitate the development, and expedite the review of treatments to treat serious conditions and fill unmet medical needs. Qualified Infectious Disease Product (QIDP) designation provides incentives to drug manufacturers to develop new treatments for serious fungal and antibiotic-resistant bacterial infections.
“The FDA’s decision to grant opelconazole Orphan Drug, Fast Track and QIDP designations acknowledges the serious unmet medical need associated with IPA and is a significant milestone in our effort to develop a treatment for IPA, a rare and debilitating disease, with less than 50% of patients responding well to first line standard of care”, commented Daniel Burgess, Chairman and CEO of Pulmocide. “We look forward to continuing to work closely with the FDA to advance this important medicine.”
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