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FDA panel backs Novartis' updated cystic fibrosis drug

New version of inhaled tobramycin therapy is simpler to use

Novartis building

A US Food and Drug Administration (FDA) advisory committee has voted in favour of approval of a new version of Novartis' inhaled tobramycin therapy for a serious lung infection that can occur in patients with cystic fibrosis (CF).

The panel voted 13 to 1 that the new version - delivered using a dry powder inhaler (DPI) - was safe and effective as a treatment for Pseudomonas aeruginosa in CF patients aged over six.

Novartis' current tobramycin product TOBI has been the standard of care of this infection in CF since it was launched in 1997, but is delivered using a nebuliser machine which is more cumbersome to set up and use.

The company carried out two trials of tobramycin inhalation powder (TIP) to support approval of the more patient-friendly formulation, which like its predecessor is delivered twice-daily but reduces administration time by 72 per cent.

The first showed that TIP was significantly more effective than placebo in maintaining patients' lung function, reduced the levels of bacteria in the lungs and clinical symptoms of CF, while the second confirmed that the new formulation was as effective as TOBI.

"While advances in research and medical treatments have substantially enhanced and extended the lives of patients with CF, the treatment burden remains very high," said Michael Konstan, the director of a CF unit at Case Western Reserve University School of Medicine in Ohio, US.

CF affects around 30,000 patients in the US and requires very convoluted treatment involving drug administration and other measures such as physiotherapy that can take two to three hours a day to complete.

"TIP could reduce this treatment burden because of its shorter administration time and greater portability compared to nebulised tobramycin," noted Konstan.

The new product is already approved in the EU and Canada, where it is sold as the TOBI Podhaler, and has helped sales of the entire franchise to accelerate since the new product appeared in selected European, Latin American and Middle Eastern markets in 2011/12.

Overall TOBI's sales in 2011 were $296m, but after several years of mid-single-digit growth now seem to be picking up, with an 11 per cent hike in the first half of 2012 to reach $152m.

6th September 2012

From: Research, Sales

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