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FDA Approves Novartis TOBI® Podhaler™ For Certain Cystic Fibrosis Patients, The First And Only Dry Powder Inhaled Antibacterial In US

"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.

The safety of TOBI Podhaler was evaluated in 425 patients who received at least one dose of TOBI Podhaler, including 273 who were exposed across three cycles. In the two placebo-controlled efficacy trials, adverse reactions reported more commonly with TOBI Podhaler compared to placebo included pharyngolaryngeal pain (sore throat), dysphonia (voice alteration) and dysgeusia (taste disturbance) in one study and cough and hypoacusis (decreased hearing) in the other study.  In the safety study, the most commonly reported adverse reactions (as defined as >10% in either treatment arm) with TOBI Podhaler were cough, lung disorder (pulmonary or CF exacerbations), productive cough, dyspnea (shortness of breath), pyrexia (fever), oropharyngeal pain (sore throat), dysphonia (voice alteration), hemoptysis (coughing up blood) and headache.

CF is a life-shortening genetic disease that affects about 30,000 children and adults in the US. It primarily impacts the lungs and digestive system, making it hard to breathe and to digest food. Pa is the leading cause of loss of lung function in people with CF .  About 80% of people with CF between the ages of 25 and 34 have Pa in their lungs.

The treatment burden for CF is very high. CF therapy requires multiple medications to be used every day with a combined average treatment time of 108 minutes per day.

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