Monday, November 24, 1997
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.