U.S. Panel Urges Quick Approval of New Cystic Fibrosis Treatment

A Food and Drug Administration advisory panel recommended rapid approval Friday of a new way to get antibiotics into the lungs of cystic fibrosis patients.

Seattle-based Pathogenesis Corp. says its TOBI, or tobramycin for inhalation, is better than intravenous doses of drugs at fighting the most deadly bacterial infection that affects those suffering from cystic fibrosis.

The FDA, which usually follows its panels’ advice, has granted the drug an expedited review and is expected to decide whether to approve it within six months, instead of the usual one year.

There were some concerns about safety. Eight of the patients using TOBI had tinnitus, a ringing of the ears that could point to hearing loss, a possible side effect of these antibiotics.

Nonetheless, TOBI had fewer side effects than intravenous delivery of the drug.

Tobramycin is formulated to fight Pseudomonas aeruginosa, which causes eight times the number of deaths and twice the number of hospitalizations compared with other bacterial infections in cystic fibrosis patients.

Cystic fibrosis affects about 30,000 Americans. It is caused by a genetic defect that makes cells produce thick, sticky mucus that clogs the lungs and intestines and can lead to infection.