The Food and Drug Administration approved the first inhaled antibiotic today, a medicine to help cystic fibrosis patients fight off deadly lung infections.
PathoGenesis Corp.'s Tobi, or tobramycin for inhalation, appears to increase the lung function of cystic fibrosis patients up to 12 percent during six months of treatment.
It sounds like a modest improvement. But in a disease so lethal that most patients die before age 30, patients had clamored for the inhaler.
"This is an important new therapy for cystic fibrosis patients," said Dr. Michael Friedman, FDA's acting commissioner.
The drug "can change the quality of life for a patient. They feel better, they function better, they have more exercise capacity," said Robert J. Beall, president of the Cystic Fibrosis Foundation, which helped fund PathoGenesis' development of the new antibiotic form.
Tobi inhalers will be available by prescription in mid-January. PathoGenesis would not immediately reveal a price.
Cystic fibrosis is an incurable genetic disease that afflicts about 30,000 Americans. Most patients die of lung failure as thick, sticky mucus clogs their airways and traps bacteria that cause infection.