Novartis announced that the FDA approved TOBI Podhaler, an inhaled powder formulation of tobramycin, for the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa bacteria in the lungs. Edward Cox, director of the Office of Antimicrobial Products in the agency’s Center for Drug Evaluation and Research, noted that the “product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler.”
In September last year, an FDA advisory panel voted to support approval of TOBI Podhaler. The regulator said that in a trial of 95 patients aged 6 years or older with CF and who were infected with P. Aeruginosa, those who received TOBI Podhaler experienced a significant increase of 12.5 percent in FEV1 compared to 0.09 percent for those treated with placebo. The FDA added that further data supporting the safety and effectiveness of the product were available from other studies enrolling 487 patients.
The agency noted that TOBI Podhaler is inhaled twice daily for 28 days and patients should then stop using the therapy for 28 days before resuming again. Novartis said the product, which was developed using its PulmoSphere technology, is expected to be available in the US in the second quarter.
An inhalation solution of tobramycin, which is delivered via a nebulizer, has been on the market for approximately 15 years under the brand TOBI. According to Novartis, Phase III study data showed that TOBI Podhaler shortened administration time for patients by approximately 70 percent compared to TOBI. “By eliminating the need for a nebulizer to deliver tobramycin and providing a small, lightweight design, TOBI Podhaler reduces administration time and improves portability for patients on-the-go,” remarked Andre Wyss, president of Novartis Pharmaceuticals.