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Published on 27 September 2010

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TOBI Podhaler recommended for approval

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TOBI Podhaler (tobramycin inhalation powder), a fast and convenient inhaled therapy for use by patients with cystic fibrosis (CF), has been recommended for approval in the European Union. The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines for the European Commission, issued a positive opinion for TOBI Podhaler as a suppressive therapy for chronic Pseudomonas aeruginosa (Pa) infections in CF patients aged six years and older.

“TOBI Podhaler combines a number of innovations that significantly improve the delivery of tobramycin, which is an established effective treatment for Pa lung infection in patients with cystic fibrosis,” said Professor Stuart Elborn, Professor of Respiratory Medicine at Queens’ University, Belfast, and President of the European Cystic Fibrosis Society.

“This therapy should help patients to lead more independent lives – an important factor considering the relatively young age of many people with this disease.”

The CHMP based its positive opinion on data showing that TOBI Podhaler provides the same efficacy as TOBI (tobramycin solution) with a comparable safety profile. TOBI is the most widely used inhaled antibiotic for chronic Pa infections in CF. TOBI Podhaler has a unique dry powder formulation, developed using novel PulmoSphere technology to produce particles that are light and porous for deep delivery into the lung. This means treatment can be given with a portable, patient-friendly device, in contrast to TOBI which is administered with a nebuliser.

Data show that patients using TOBI Podhaler completed their tobramycin treatment in five to six minutes instead of 20 minutes with TOBI, a reduction of 72%. Nebulised treatments require additional time for assembly and disinfection, unlike TOBI Podhaler, which also does away with the need for refrigeration of the active compound and a power source for the delivery device. A study found that patients treated with TOBI Podhaler had significantly higher treatment satisfaction than those treated with TOBI.

Due to the complexity of existing anti-Pa treatment, most patients do not fully adhere to their therapy. In addition, many patients do not clean their nebulisrs properly and these are often contaminated. With TOBI Podhaler, the inhaler device is disposable and the dry formulation potentially reduces the risk of bacterial contamination.

“TOBI Podhaler shows how we are applying innovative technologies to better meet the needs of patients and their families,” said David Epstein, Division Head of Novartis Pharmaceuticals. “TOBI Podhaler also underscores our long-term commitment to improving the quality of care for patients with diseases such as cystic fibrosis and helping them to lead longer and more active lives.”

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Novartis



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