Novartis’ cystic fibrosis inhaler approved by US FDA
Novartis’ TOBI Podhaler has been approved for use in the United States by the FDA, to treat a type of bacterial lung infection in patients with cystic fibrosis.
The TOBI Podhaler (tobramycin inhalation powder) is a plastic, handheld inhaler device that contains a dry powder formulation of tobramycin, an antibiotic used to treat Pseudomonas aeruginosa infection. Pseudomonas aeruginosa is a bacterium that causes lung infections.
“Today’s approval broadens the available delivery mechanism options for patients with cystic fibrosis who require treatment for P. aeruginosa. This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler.”
Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Clinical trials of 95 pediatric and adult cystic fibrosis patients evaluated the effectiveness of TOBI Podhaler. The study was designed to determine the improvement in lung function by measuring the change in forced expiratory volume in one second (FEV1). Patients treated with TOBI Podhaler experienced a statistically significant increase of 12.5%.
Cystic fibrosis is a genetic disease that affects approximately 30,000 children and adults in the US.
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