FDA Approves Tobi Podhaler For Cystic Fibrosis

On March 22, 2013 the U.S. Food and Drug Administration announced approval of a new drug to treat a lung infection common in patients with cystic fibrosis. The drug, Tobi Podhaler (tobramycin inhalation powder) is approved for use in cystic fibrosis patients with Pseudomonas aeruginosa. P. aeruginosa is a bacterium that causes lung infections, which are a frequent serious complication seen in cystic fibrosis.

TOBI Podhaler is a plastic, handheld inhaler device that contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again. Tobi Podhaler represents a significant improvement over currently available treatments because it is the first antibacterial formulation available as an orally inhaled dry powder device.

The effectiveness of Tobi Podhaler was evaluated in a study of 95 pediatric and adult patients. The study found that Tobi Podhaler produced a statistically and clinically significant improvement in forced expiratory volume (FEV1) in patients treated with Tobi Podhaler (12.5% increase in FEV1), compared to placebo (0.09% increase in FEV1). Other safety and efficacy data were available from studies that enrolled a total of 487 patients.

Common side effects of Tobi Podhaler, as observed in the clinical trials, include cough, including a cough that produces phlegm or mucus; coughing up of blood (hemoptysis); lung disorder; shortness of breath; fever; mouth and throat pain; changes in voice volume or quality (dysphonia); and headache.
Tobi Podhaler is marketed by Novartis AG, and is currently approved in the European Union, Switzerland, Canada, and other countries.

For more information, see the press release at the FDA’s website: FDA Press Release

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