Windtree Therapeutics' (WINT) AEROSURF Receives FDA Fast Track Designation

September 19, 2016 4:33 PM EDT
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Windtree Therapeutics, Inc. (Nasdaq: WINT) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AEROSURF® (lucinactant for inhalation) for the treatment of premature infants with respiratory distress syndrome (RDS). AEROSURF is a novel, investigational combination drug/device product that is being developed to deliver aerosolized KL4 surfactant to premature infants with RDS, potentially reducing the need for invasive endotracheal intubation and mechanical ventilation to administer surfactant therapy.

"This Fast Track designation for AEROSURF underscores the significant need to reduce the use of invasive intubation and mechanical ventilation, which are required to administer surfactant therapy, but may result in serious complications and increase the risk for other respiratory conditions," commented Craig Fraser, President and Chief Executive Officer. "By enabling non-invasive delivery of our aerosolized KL4 surfactant, we believe that AEROSURF will address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits. We look forward to continuing our work with the FDA to advance AEROSURF through the clinical development and regulatory approval process, with the goal of bringing a transformative therapy to treat premature infants in an expedited time frame."

The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Drugs that receive this designation benefit from more frequent communications and meetings with FDA to review the drug's development plan including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval. Drugs with Fast Track Designation may qualify for priority review to expedite the FDA review process, if relevant criteria are met.

AEROSURF is currently being studied in a phase 2b clinical trial in premature infants 26 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS. The phase 2b trial includes clinical sites in North America, Europe and South America.

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