FDA OKs 1st Inhaled Antibiotic to Aid Cystic Fibrosis Patients

The Food and Drug Administration approved the nation’s first inhaled antibiotic Tuesday, a medicine called Tobi that promises to improve the lungs of thousands of cystic fibrosis patients.

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.

Particularly dangerous is Pseudomonas aeruginosa, a bacterium that afflicts 80% of cystic fibrosis patients by adulthood and increases their risk of death by eight times.

The standard treatment is intravenous tobramycin, usually given in a hospital. But even the best patients lose 2% of lung function every year, and doctors can’t give higher, more effective doses because the drug’s path through the bloodstream can severely damage kidneys and cause deafness.

Tobi, or tobramycin for inhalation, appears to increase patients’ lung function up to 11% during six months of treatment, an important improvement.

Most patients die before age 30, and patients had clamored for the new inhaler. Manufacturer PathoGenesis Inc. said the drug will be available by prescription the week of Jan. 5.

It “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.

“I was breathing easier and coughing less. . . . I noticed at school, in PE, I could keep up with my friends during the running days,” said Brett Barker, 15, of Seattle, who had been hospitalized every six months for lung infections but avoided hospitalization during two years of testing Tobi.