Nektar Inhaled Anti Infective Given Orphan Designation
Posted on: Thursday, 16 February 2006, 21:00 CST
The FDA has granted orphan drug designation to Nektar's amphotericin B inhalation powder for prevention of pulmonary fungal infections in immunosuppressed patients.
Orphan products are developed to treat diseases or conditions that affect fewer than 200,000 people in the US. The orphan drug act provides a seven-year period of exclusive marketing to the first sponsor who obtains marketing approval for a designated orphan drug.
Using a small proprietary pocket size inhaler, the company has conducted two phase I trials and has long-term toxicity studies underway to support the planned pivotal trials early next year.
Immunosuppressed patients, for example those receiving organ or stem cell transplants, or chemotherapy or radiation therapy for hematologic malignancies, commonly develop fungal infections in their lungs which spread throughout the body (aspergillosis).
Inhaling amphotericin B inhalation powder into the lungs prior to developing an aspergillosis infection may potentially reduce the incidence of these infections as well as the subsequent high morbidity and mortality and significant treatment costs associated with them.
Nektar developed the amphotericin B inhalation powder to target the lungs directly with this potent, broad spectrum, fungicidal "gold-standard" antifungal drug, while potentially eliminating systemic toxicities associated with current formulations of amphotericin B which must be delivered intravenously.
"Given the high incidence of invasive aspergillosis in immunocompromised patients, and high mortality rates despite available therapies, this potential new therapy could represent a significant breakthrough in antifungal medicine," said Dr Kieren Marr, assistant professor medicine, allergy and infectious diseases, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Source: Datamonitor
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