FDA questions efficacy of Novartis cystic fibrosis drug tobramycin

The US Food and Drug Administration has questioned the efficacy of Novartis' experimental cystic fibrosis drug tobramycin ahead of an advisory panel meeting this week.

The US Food and Drug Administration has questioned the efficacy of Novartis' experimental cystic fibrosis drug tobramycin ahead of an advisory panel meeting this week.

Documents released by the FDA on 31 August 2012 revealed that the administration has doubts over whether the inhaled powder truly helped cystic fibrosis patients with their breathing in clinical trials.

The doubts stem from the results of two clinical trials, with only one trial demonstrating tobramycin to work better than a placebo. The FDA also questioned whether the new product was as effective and safe as the nebulised version, or whether it worked as suggested over time.

The drug's efficacy over time is crucial for the treatment of cystic fibrosis patients, given the prevalence of chronic lung infections in sufferers of the genetic disease. Novartis is seeking approval of the antibiotic powder, which the company claims is a more convenient treatment than Tobi, the older, nebulized version