FDA votes to support inhaled powder form of tobramycin (Novartis) for patients with Cystic Fibrosis

An FDA drug advisory committee has voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (TIP), from Novartis, for the management of Cystic Fibrosis (CF) patients whose lungs contain bacteria called Pseudomonas aeruginosa (Pa). It 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 the powdered form of the drug. The studies found that treatment with this form resulted in improved lung function. Tobramycin is currently marketed in the US by Novartis as Tobi (tobramycin inhalation solution), 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.