BETHESDA, Md. - An FDA advisory committee on Friday unanimously asserted its confidence in the safety and efficacy of PathoGenesis Corp.'s TOBI (tobramycin solution for inhalation) for the treatment of pseudomonal lung infections in patients with cystic fibrosis. The antibiotic would be added to conventional therapy to control lung infections that are the primary cause of disability and death in CF patients. TOBI is a preservative-free form of tobramycin that is given in aerosol form.

Anti-Infective Drugs Advisory Committee members, invited consultants and officials of the Cystic Fibrosis Foundation were enthusiastic both about the potential benefits of TOBI as well as the way PGNS designed and conducted its clinical trials. This could be important not only because the company is hoping for widespread adoption of the drug among CF patients, but also because it is planning to develop a series of other antibiotics for the disease.