EU approval rec for TIP

Novartis International AG: Novartis receives EU approval recommendation for TOBI® Podhaler®, a fast and simple therapy that helps reduce treatment burden for cystic fibrosis patients

Fri Sep 24, 2010 9:17am EDT


Novartis International AG / Novartis receives EU approval recommendation for TOBI

Podhaler, a fast and simple therapy that helps reduce treatment burden for cystic fibrosis patients processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.




CHMP supports approval of TOBI Podhaler, a new dry powder form of tobramycin for treating chronic P. aeruginosa lung infection in cystic fibrosis patients over six




Data show new formulation reduces administration time by 72% compared to TOBI, with same

efficacy[1] and using more convenient, patient-friendly device



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Cystic fibrosis is a life-threatening genetic disease primarily affecting children and young adults - complex daily treatment reduces their ability to lead normal lives



Basel, September 24, 2010 - TOBI® Podhaler® (tobramycin inhalation powder), a fast and

convenient inhaled therapy[1] 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[2] as TOBI® (tobramycin solution) with a comparable safety profile[2]. TOBI is

the most widely used inhaled antibiotic for chronic Pa infections in CF[3]. 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 nebulizer.



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%[1]. Nebulized

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[1].



Due to the complexity of existing anti-Pa treatment, most patients do not fully adhere

to their therapy[4],[5],[6]. In addition, many patients do not clean their nebulizers

properly and these are often contaminated[7],[8],[9],[10]. 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."



Cystic fibrosis (CF) is a life-threatening genetic disease that affects the internal

organs, especially the lungs and digestive system, by clogging them with thick mucus

making it hard to breathe and digest food. A total of 70,000 patients have been

diagnosed with CF worldwide[11]. Symptoms usually develop within the first year of life

and only half of CF patients live to over 35 years of age[12]. In 90% of cases, death is

due to a progressive decline in lung function often made worse by chronic Pseudomonas

aeruginosa infection[13].



The first launch of TOBI came in 1997 and it is now approved in 46 countries including

the US and EU for the treatment of Pseudomonas aeruginosa in CF patients aged six years

old and above.



TOBI Podhaler was submitted for EU approval in December 2009 and is not yet approved in

any country. The European Commission generally follows the recommendations of the CHMP

and is expected to make a decision within three months.