The US FDA grants fast track designation to Nektar's Amphotericin B Inhalation Powder (ABIP) for prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy, including those receiving organ or stem cell transplants, or treated with chemotherapy or radiation for haematologic malignancies (leukaemia).
The FDA granted fast track designation for the following reasons: Invasive aspergillosis is a serious infection that usually affects immunosuppressed patients receiving organ or stem cell transplants, or treated with chemotherapy or radiation for hematologic malignancies. The infection 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, including those receiving organ or stem cell transplants, or treated with chemotherapy or radiation for haematologic malignancies. Therefore, there is an unmet medical need for a new treatment.
Under fast track, 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 senior VP of research and development. "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," he added.
Nektar announced in February 2006 that the FDA had granted US orphan drug designation to ABIP for the prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy.
ABIP is designed to target the site of infection directly with a novel formulation of amphotericin B, a broad spectrum, "gold-standard" antifungal drug. Nektar's innovative formulation and pulmonary delivery method could potentially eliminate systemic, dose-limiting toxicities found with current formulations of amphotericin B that are delivered intravenously.