In a late-stage study of patients with chronic obstructive pulmonary disease (COPD), Novartis's once-daily drug Onbrez (indacaterol) was found to be significantly better at improving lung function and reducing breathlessness than twice-daily salmeterol, the key component of GSK's drug Advair.
The 12-week study called INSIST involved 1,123 patients aged 40 years or above with moderate-to-severe COPD in seven countries. Results showed that 150 mg of indacaterol, delivered once daily via the Breezhaler, provided 24-hour bronchodilation superior to 50 mg of salmeterol twice-daily at the end of 12 weeks' treatment. Bronchodilation was measured by the volume of breath in one second. Also, 69.4% of patients using the Onbrez Breezhaler showed a reduction in breathlessness compared to 62.7% on salmeterol. This study's results are supported by another recently published study.
"Patients with COPD require treatment that combines a sustained improvement in lung function with better clinical outcomes," said the study's principal investigator, Dr Stephanie Korn of the Pulmonary Department at Mainz University Hospital in Mainz, Germany. "The results of INSIST confirm that indacaterol is potentially an attractive maintenance treatment option for these patients."
Controls Symptoms of Lung Damage From Smoking
COPD refers to a group of lung diseases that block airflow and make it increasingly difficult to breathe. Often, but not always, caused by smoking, COPD is now the fourth leading cause of death in the U.S. and is also significant cause of long-term disability. Damage to the lungs can't be reversed, so treatment focuses on controlling symptoms and minimizing further damage.
Worldwide, 210 million people are affected by COPD, and it's projected to be the third leading cause of death by 2020. In 2005, COPD caused an estimated 126,005 U.S. deaths in people older than 25 years -- an 8% increase from 2000. The number of people who have COPD is on the rise, with more than 12 million are currently diagnosed with it in the U.S., and an equal number estimated to have COPD without realizing it.
Given those numbers, Onbrez Breezhaler, the first new inhaled treatment for COPD in seven years, has the potential to be a blockbuster with more than $1 billion in sales annually. Sales of London-based GSK's asthma and COPD treatment Advair were £1.3 billion ($2 billion) in the second quarter.
While Onbrez Breezhaler has been approved in more than 40 countries and the European Union, in the U.S. its approval is subject to the Food and Drug Administration's review of additional clinical data, which Novartis expects to file by the end of 2010.