Tobramycin inhalation powder regulatory update

FDA's Anti-Infective Drugs Advisory Committee voted 13-1 that Novartis demonstrated adequate evidence of safety and evidence to support the use of tobramycin inhalation powder for the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections. The inhaled, dry powder formulation of tobramycin is approved in the EU, Canada, Switzerland and Australia. Novartis markets a nebulizer formulation under the name TOBI tobramycin.

The recommendation comes despite briefing documents last month that raised several issues about the data, including a "major limitation" in the only Phase III trial that showed significant efficacy over placebo. The product met the primary endpoint of improving percent predicted forced expiratory volume in 1 second (FEV1), but FDA reviewers said the primary analysis excluded 41% of the randomized population and is "seriously limited." An analysis of all randomized patients from the trial showed a smaller magnitude of treatment effect, according to the documents. ...