"TOBI Podhaler is an example of how Novartis is utilizing innovative technologies to better meet the needs of patients. 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," said Andre Wyss, President of Novartis Pharmaceuticals Corporation. "It also underscores our long-term commitment to the cystic fibrosis community."TOBI Podhaler was studied in a Phase III clinical program involving 674 CF patients aged six years and older with Pa in their lungs, of whom 425 patients received at least one dose of TOBI Podhaler. Two trials evaluated the efficacy of TOBI Podhaler vs. placebo, while a third trial assessed the safety of TOBI Podhaler vs. TOBI. All studies evaluated TOBI Podhaler at the approved dose of 112 mg twice daily (the contents of four 28 mg capsules per dose) in cycles of 28 days on, immediately followed by 28 days off treatment. Results of the efficacy studies showed that TOBI Podhaler improved lung function compared to placebo.
FDA Approves Novartis TOBI® Podhaler™ For Certain Cystic Fibrosis Patients, The First And Only Dry Powder Inhaled Antibacterial In US
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