Novartis' TOBI Podhaler receives Health Canada NOC for Pa treatment in CF patients

Apr 6 2011

Novartis Canada announced today that it has received Health Canada Notice of Compliance (NOC) for TOBI^® Podhaler^®, a fast and convenient inhaled therapy for cystic fibrosis (CF) patients aged six and over. Canadian CF patients will be the first in the world to have access to TOBI^® Podhaler^®. The TOBI^® Podhaler^® offers a new dry-powder formulation of tobramycin delivered in a convenient and portable breath-activated inhaler for treating Pseudomonas aeruginosa (Pa) infections in CF patients.

"It is anticipated that the introduction of portable therapy for Pa infections will be a tremendous advance for CF patients, and may have a significant, positive impact on quality of life and treatment success," says Dr. Felix Ratjen, Paediatric Respirologist. "By eliminating the need for a nebulizer and regular disinfection of the equipment, it is anticipated that the risk of bacterial contamination will be greatly reduced while patient compliance will likely improve. Ultimately, this will lead to more effective treatment and help CF patients live more active, normal lives."

Pseudomonas aeruginosa infection is one of the most common pulmonary pathogens for Canadians with CF.  As a CF patient ages, they are more likely to develop a Pa infection. By the age of 25 years, more than 70 per cent of CF patients will develop a lung infection due to Pa. This common respiratory pathogen is one of the main drivers of morbidity and mortality in CF.

Due to the complexity of current anti-Pa treatment, most patients do not fully adhere to their therapy. Although disinfection and cleaning are suggested every time a nebulizer is used, it is estimated that only 30 per cent of patients comply, and  some never clean their nebulizer. TOBI^® Podhaler^® is a dry formulation with a disposable inhaler device which can be replaced weekly and potentially reduce the risk of bacterial contamination.

In addition, data shows that patients using TOBI^® Podhaler^® completed their tobramycin treatment in five to six minutes, a reduction of 72 per cent in the time traditionally required to administer nebulized tobramycin. By improving the delivery of tobramycin and reducing treatment administration times, the TOBI^® Podhaler^® has the potential to help patients lead more independent lives.

Unique formulation and delivery system

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 current treatment options which are administered with a nebulizer.

By eliminating the use of a nebulizer, TOBI^® Podhaler^® does not require additional time for assembly and disinfection of the delivery device. In addition, TOBI^® Podhaler^® removes the need for refrigeration 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^®.

In addition, TOBI^® Podhaler^® was generally well tolerated during clinical trials. The most frequent reactions associated with TOBI^® Podhaler^® during the first treatment cycle were: cough, dysphonia, productive cough and oropharyngeal pain. The frequency of these adverse reactions decreased over the study duration.

Source: NOVARTIS PHARMACEUTICALS CANADA INC.