FDA staff question Novartis cystic fibrosis drug
WASHINGTON Aug 31 (Reuters) - U.S. drug reviewers questioned whether Novartis AG's inhaled antibiotic treatment truly helped cystic fibrosis patients breathe better, according to documents posted online on Friday.
Staff from the U.S. Food and Drug Administration released their review of Novartis's tobramycin inhaled powder ahead of an advisory committee of outside experts, which will vote on whether to recommend the drug next Wednesday.
Novartis is seeking approval of the inhaled antibiotic powder as a more convenient alternative than nebulized solution. The antibiotic attacks an infection that often occurs in the lungs of patients with cystic fibrosis, a rare genetic disease.