Nektar Antifungal Fast-Tracked By FDA
Posted on: Tuesday, 23 May 2006, 16:57 CDT
The FDA has granted fast track designation to Nektar Therapeutics' amphotericin B inhalation powder for the prevention of pulmonary fungal infections in patients at risk of aspergillosis due to immunosuppressive therapy.
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.
Source: Datamonitor
Related Articles
- Hospitals, Healthcare Providers to Save With New Premier Agreement for Aquapheresis Therapy Products
- Patient's Own Infection-Fighting T Cells Put Late-Stage Melanoma Into Long-Term Remission
- Teva Pharmaceutical's Altered Peptide Ligand Copaxone Boasts the Greatest Patient Share Among First- and Second-Line Therapies for the Treatment of Multiple Sclerosis
- Radianse Focuses on Low-Cost, Smart Design to Make Patient Tracking Pervasive
- Bi-State Region Patient-Tracking System Speeds Emergency Response, Improves Patient Care
- Report: Costs Soar When Hospital Patients Are Infected
- Pluristem Strengthens Business Strategy Company to Focus on Commercializing Cell Therapy Products
- Pluristem Strengthens Business Strategy, Company to Focus on Commercializing Cell Therapy Products
- Nearly 12,000 Pa. Patients Got Infections
- Pa.: Nearly 12,000 Patients Got Infections
 |
 |
User Comments (0)
RSS Feeds