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FDA Advisory Committee supports use of tobramycin inhalation powder from Novartis for patients with cystic fibrosis
Date:9/5/2012

moSphere™ technology. This enabled the creation of hollow porous particles of tobramycin that can be delivered as a dry powder rather than as a nebulized solution.

"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," said Tim Wright, Global Head of Development, Novartis Pharma. "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."

CF is a life-threatening 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. The treatment burden for CF is extremely high, with as many as 20 medications having to be used every day with a combined average treatment time of 108 minutes. The overall time to administer all the necessary treatments and perform physiotherapy and exercise can be as much as two to three hours each day.

Pa is a 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. Once a CF patient is infected with Pa in their lungs, it never completely goes away.

The Phase III clinical trial program consisted of two trials comparing TIP to placebo and one trial comparing TIP to TOBI, at the proposed TIP dosage of 112 mg twice-daily (inhaling the contents of four 28 mg capsules per dose) in a cycle of 28 days on, 28 days off treatment. Compared to patients on placebo, patients treated with TIP showed improved lung function. TIP also demonstrated comparable efficacy to TOBI 300 mg administered via a nebulizer with a reduction in administration time of approximately 70%, saving about 13 hours per treatment cycle. This does not include the time
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SOURCE Novartis
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