FDA approves new CF treatment
An advisory panel from the U.S. Food and Drug Administration in Rockville, MD, voted unanimously to approve a new delivery system to get antibiotics into the lungs of cystic fibrosis (CF) patients. The Tobramycin for Inhalation (TOBI) system is formulated to fight Pseudomonas aeruginosa, the most deadly bacterial infection affecting CF patients.
"Clearly TOBI will become a major weapon in our fight to stop the progression of this destructive lung disease," says Bob Beall, President and CEO of the Cystic Fibrosis Foundation in Bethesda, MD. TOBI uses a nebulizer that turns the medicine into an aerosol and provides a more effective means to get antibiotics into the lungs than intravenous antibiotic doses. In addition, studies indicate that TOBI produces fewer side effects than IV administration. In trials of 468 patients in 69 CF care centers, TOBI treatment resulted in improved lung function, 26% fewer hospitalizations, one-third fewer days in the hospital, and decreased numbers of bacteria.
However, several panelists expressed concerns about possible side effects. Of the 468 patients involved in the trials, eight developed tinnitus, a ringing in the ears that could precede hearing loss. In addition, there were inconclusive data suggesting possible drug resistance. Even so, the FDA has granted TOBI an expedited review. Usually following the advice of its panel, the FDA is expected to give approval within six months, instead of the usual 12 months.