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| |  FDA Committee Recommends Approval Of Tobi For CF Lung Infections SEATTLE, WA -- November 21, 1997 -- By an unanimous vote of nine to zero, the Anti-Infective Drugs Advisory Committee of the United States Food and Drug Administration (FDA) today recommended approval of Tobi(TM) (tobramycin solution for inhalation) for treating pseudomonal lung infections in people with cystic fibrosis. The committee's recommendation is not binding but will be considered by the FDA in completing its expedited review of the drug application, which was submitted in July of this year by PathoGenesis Corp. During today’s meeting, the committee reviewed the safety and efficacy data from two Phase III clinical trials of Tobi in cystic fibrosis patients whose lungs were infected with Pseudomonas aeruginosa. The six-month studies demonstrated that Tobi improved lung function and reduced bacterial levels in the sputum. In addition, a pre-planned combined analysis of both studies showed a reduction in days spent in the hospital and in use of intravenous antibiotics. Overall adverse events were comparable between the Tobi and placebo groups. Transient tinnitus (ringing in the ears) and voice alteration (hoarseness) were the only side effects reported more frequently by the Tobi groups. The drug was tested in people between the ages of six and 63. If approved, Tobi will be the first inhaled antibiotic solution indicated for treating pseudomonal lung infections in people with cystic fibrosis – and only the second drug approved for cystic fibrosis patients in the past 30 years. Tobi has received an orphan drug designation from the FDA. Cystic fibrosis is a genetic disease affecting about 30,000 people in the U.S. Their median age of survival is about 31. The disease is characterized by thick, sticky mucus that accumulates in the lungs and can lead to lifelong pseudomonal infections. To treat these lung infections, Tobi is designed for at-home aerosol administration using a nebulizer and compressor. In the six-month clinical trials, the drug was administered twice a day over three alternating cycles of 28 days on drug, 28 days off drug.
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