FDA grants fast track designation to Nektar's Amphotericin B Inhalation Powder

By Lisa Kerner

Erie, Pa., May 22 - Nektar Therapeutics received fast track designation from the Food and Drug Administration for the company's Amphotericin B Inhalation Powder (ABIP) for prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy.

The patient group includes patients receiving organ or stem cell transplants or treated with chemotherapy or radiation for hematologic malignancies (leukemias), according to a company news release.

The fast track designation allows the FDA to expedite the review of new drugs that are intended for serious or life-threatening conditions that address unmet medical needs. Also, Nektar may submit portions of the marketing application for review on a rolling basis prior to completion of the final registration package for the product.

ABIP received orphan drug status from the FDA in February for the prevention of pulmonary aspergillosis in high-risk immunosuppressed patients, giving Nektar seven years of marketing exclusivity.

"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," senior vice president of research and development David Johnston said in the release.

"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."

Nektar said ABIP is in a multidose phase 1 study.

Located in San Carlos, Calif., Nektar is a biopharmaceutical company that develops drug delivery technologies.

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