U.S. FDA OKs Novartis inhaler to treat lung infection in cystic fibrosis patients
March 22 (Reuters) - U.S. health regulators approved on Friday a hand-held inhaler made by Swiss drug maker Novartis AG to treat a type of bacterial lung infection that often affects cystic fibrosis patients.
Novartis's TOBI Podhaler contains a dry powder formulation of tobramycin, an antibiotic used to treat lung infection caused by the pseudomonas aeruginosa bacteria.
"This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler," said Dr. Edward Cox, director of the office of antimicrobial products at the U.S. Food and Drug Administration.
About 30,000 pediatric and adult patients in the United States are afflicted with cystic fibrosis, a genetic disease that causes the body to produce thick mucus that builds up in the lungs and blocks airways, the FDA said.
This build up becomes a breeding ground for bacteria such as pseudomonas aeruginosa to grow and cause lung infection.
Most cystic fibrosis patients infected with this bacteria are currently treated with a nebulizer, a larger drug delivery device that converts medication into a vapour form that can be inhaled.
The FDA approval is based on tests on 95 patients conducted using TOBI Podhaler that proved the device was effective at improving the lung function in those patients.
The antibiotic powder in Podhaler needs to be inhaled twice daily using Podhaler for 28 days, after which the therapy should be halted for the same number of days before it is resumed, the FDA said.
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