The Anti-Infective Drugs Advisory Committee (AIDAC) to the US Food and Drug Administration (FDA) has recommended the use of Novartis's tobramycin inhalation powder (TIP) to treat cystic fibrosis (CF) patients whose lungs contain bacteria called Pseudomonas aeruginosa (Pa).
TIP is intended for use in CF patients aged six years and older whose lung function is within a certain range.
The AIDAC approval was based on three phase III clinical studies that involved more than 650 CF patients aged six years and older, of whom 425 patients received at least one dose of TIP.
The trial also compared TIP to TOBI (tobramycin inhalation solution, USP), which is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.
TIP clinical investigator Michael Konstan said while advances in research and medical treatments have substantially extended the lives of patients with CF, the treatment burden remains high.
"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," Konstan added.
Investigational TIP, which is developed using proprietary Novartis PulmoSphere technology, is a new inhaled formulation of tobramycin that contains dry powder in capsules delivered via a dry powder inhaler.
Novartis Pharma global head of development Tim Wright said, "The company is dedicated to introducing innovative, safe and effective treatment options for patients and physicians, and we look forward to working closely with the FDA as it finalizes its review of TIP."
