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FDA Advisory Committee supports use of tobramycin inhalation powder from Novartis for patients with cystic fibrosis
Date:9/5/2012

EAST HANOVER, N.J., Sept. 5, 2012 /PRNewswire/ -- The Anti-Infective Drugs Advisory Committee (AIDAC) to the US Food and Drug Administration (FDA) today voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (TIP) for the management of cystic fibrosis (CF) patients whose lungs contain bacteria called Pseudomonas aeruginosa (Pa). Pa is the leading cause of loss of lung function in people with CF. TIP is intended for use in CF patients aged six years and older whose lung function is within a certain range (i.e., FEV1 between 25% and 80% predicted).

The AIDAC based its recommendation on three Phase III clinical studies involving more than 650 CF patients aged six years and older, of whom 425 patients received at least one dose of TIP. The studies found that treatment with TIP resulted in improved lung function.

"While advances in research and medical treatments have substantially enhanced and extended the lives of patients with CF, the treatment burden remains very high," said TIP clinical investigator Michael Konstan, MD, Chairman of the Department of Pediatrics and Director of the Cystic Fibrosis Center at Rainbow Babies and Children's Hospital and Case Western Reserve University School of Medicine in Cleveland, Ohio. "Today's vote is exciting for the CF community as TIP could reduce this treatment burden because of its shorter administration time and greater portability compared to nebulized tobramycin."

Tobramycin is currently marketed in the US by Novartis Pharmaceuticals Corporation as TOBI® (tobramycin inhalation solution, USP), and is administered as a nebulized solution with an indication similar to that proposed for TIP. In contrast, investigational TIP is a new inhaled formulation of tobramycin consisting of dry powder in capsules delivered via a dry powder inhaler. The new formulation was developed using proprietary Novartis Pul
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SOURCE Novartis
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