FDA Staff Question Efficacy of Tobramycin Inhaled Powder for Cystic Fibrosis
Approval decision scheduled for September 5 (Aug. 31)
According to an August 31 report from Reuters, FDA reviewers have questioned whether tobramycin inhaled powder, from Novartis, truly improves breathing in cystic fibrosis patients. Only one of two clinical trials showed that the tobramycin powder worked better than placebo.
The FDA staff released their opinion ahead of the agency’s approval meeting, which is scheduled for Wednesday, September 5.
Novartis is seeking an indication for the inhaled powder as a more convenient alternative to the nebulized solution (TOBI).
Tobramycin is an aminoglycoside antibiotic.
For more information, visit the Reuters Web site.