Novartis’ Tobramycin Inhalation Powder May Face Questions Over Study Endpoint
This article was originally published in The Pink Sheet Daily
Executive Summary
Novartis’ inhalation powder version of the antibiotic tobramycin appears to be much more convenient in treating Pseudomonas aeruginosa infections in cystic fibrosis patients than the currently marketed nebulized solution (Tobi), but the appropriateness of the FEV1 endpoint is likely to be a matter of dispute during advisory committee review.