Novartis hails longer-lasting COPD drug
pharmafile | September 20, 2010 | News story | Research and Development, Sales and Marketing | COPD, Novartis, Onbrez Breezhaler
A phase III treatment for COPD has demonstrated superior results over GSK’s established Serevent (salmeterol).
Data from Novartis’ INSIST study shows its once-daily Onbrez Breezhaler (indacterol) is significantly better at improving lung function and reducing breathlessness than twice-daily Serevent (salmeterol).
Onbrez Breezhaler is already approved in Europe and other markets, but the FDA has requested additional data and Novartis expects to file for approval in the US by the end of the year.
COPD affects 210 million people worldwide and is projected to be the third leading cause of death by 2020.
Associated with tobacco smoking, COPD is a life-threatening disease which causes obstruction of airflow in the lungs – resulting in debilitating bouts of breathlessness.
Largely considered a disease of the elderly, research has shown that a majority of COPD patients are in fact under the age of 65.
The Novartis’ study involved over 1,000 patients and showed that Onbrez Breezhaler provided superior 24-hour bronchodilation to salmeterol at the end of 12 weeks’ treatment.
Trevor Mundel, global head of development at Novartis, said: “By demonstrating the benefits that Onbrez Breezhaler can bring to patients with COPD, this study affirms our confidence in this medicine and in the indacaterol-based combination therapies currently under development.”
Dr Stephanie Korn, the study’s principal investigator, added: “Patients with COPD require treatment that combines a sustained improvement in lung function with better clinical outcomes. The results of INSIST confirm that indacaterol is potentially an attractive maintenance treatment option for these patients.”
Brett Wells
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