The Anti-Infective Drugs Advisory Committee (AIDAC) of the FDA voted 13 to 1 in favor of approval of Novartis’s tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa-infected cystic fibrosis patients six years old and older. Briefing materials for the meeting had questioned the safety and efficacy of TIP and whether it had any advantages compared to tobramycin inhalation solution.
The dry powder formulation of tobramycin, created using PulmoSphere particle engineering technology, is delivered by a capsule-based DPI and will be marketed as TOBI Podhaler if approved. Novartis already markets TIP as TOBI Podhaler in Canada and Europe.
Novartis Global Head of Development Tim Wright commented, “Novartis is committed to addressing the needs of patients with CF, and we are very encouraged by the Advisory Committee’s vote to support the use of TIP in the US. The company is dedicated to introducing innovative, safe and effective treatment options for patients and physicians, and we look forward to working closely with the FDA as it finalizes its review of TIP.”
Read the Novartis press release.
