Pulmocide’s lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

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.”

To Read the Complete Article at BioSpace Click Here

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

Stock image by @SergeyNivens a from Depositphotos