Amphotericin B inhalation powder represents the first inhaled anti-fungal therapy under development for immunosuppressed patients. The fast track designation includes patients receiving organ or stem cell transplants, or treated with chemotherapy or radiation for hematologic malignancies.
The FDA granted fast track status as invasive aspergillosis is a serious infection that is often lethal in medically immunosuppressed patients. There is no approved agent for prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy. Therefore, there is an unmet medical need for a new treatment.
Under the fast track designation, Nektar is now eligible to submit portions of the marketing application for review on a rolling basis prior to completion of the final registration package for the product.
“We are pleased that the FDA recognizes that Nektar's product for this indication meets the criteria for fast track designation and this is an important step toward providing a much-needed medical solution to protect against life-threatening pulmonary infections,” said Dr David Johnston, Nektar's senior vice president of R&D. “Our product could represent a major paradigm shift in antifungal therapies as we aim to prevent infections by targeting the lungs directly and therefore avoid the serious systemic and dose-limiting side effects of intravenous and oral therapies.”
The drug candidate is currently in a multi-dose phase I study and has generated encouraging preclinical and phase I data to date.