The FDA briefing materials for the September 5, 2012 meeting of the Anti-Infective Drugs Advisory Committee, which will consider the use of Novartis’s Tobi tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa infections in cystic fibrosis patients, question both the efficacy and safety of the product, especially when compared to TOBI tobramycin inhalation solution.
The questions set our for the advisory committee are:
1. Has the applicant demonstrated adequate evidence of efficacy to support the use of tobramycin inhalation powder (TIP) in the management of cystic fibrosis patients infected with Pseudomonas aeruginosa? If not, what additional data are needed?
2. Has the applicant demonstrated adequate evidence of safety to support the use of TIP in the management of cystic fibrosis patients infected with Pseudomonas aeruginosa? If not, what additional data are needed?
3. Please discuss the implications of the changes in mean inhibitory concentrations (MICs) seen after treatment with TIP compared to tobramycin solution for inhalation.
4. Should the application be approved, please discuss the role of TIP in the compared to tobramycin solution for inhalation.
Read the FDA briefing materials.
