Novartis' development compound indacaterol demonstrated effective and well-tolerated treatment of asthma and chronic obstructive pulmonary disease (COPD) over 24 hours with a rapid onset of action, according to new data presented at the congress of the European Respiratory Society (ERS) in Copenhagen, Denmark.
"The combination of 24-hour efficacy and a reassuring safety profile suggests that in time, a once-daily dose of indacaterol could become a new standard of care for bronchodilation in asthma and COPD," Joerg Reinhardt, Global Head of Development, Novartis Pharma AG said adding, "We are now concentrating on the development of this important new therapy for the benefit of patients who suffer from these debilitating and sometimes fatal diseases."
The results of a series of clinical studies show that indacaterol (formerly known as QAB149) could become the first in a new class of 'once-daily beta2-agonists', offering potential therapeutic benefits for patients with asthma and COPD. Indacaterol could be the first beta2-agonist to be taken only once-daily providing full 24 hour symptom control with a single administration, in contrast to currently-available long-acting beta2-agonists (LABAs) such as salmeterol and formoterol which have to be taken twice-daily.
Key indacaterol data presented at ERS included those demonstrating its 24-hour bronchodilator efficacy in COPD, as well as in asthma. Even at high doses, indacaterol demonstrated a good overall safety profile with no concerns over key adverse events sometimes associated with beta2-agonists. These data reinforce the results of preclinical studies.
"Considered together, these results provide important insights into the future therapeutic potential of indacaterol, the first in a new generation of drugs that could accurately be described as 'once-daily beta2-agonists'," said Prof. Stephen Holgate, Southampton General Hospital, UK.
The efficacy of indacaterol in both asthma and COPD was demonstrated in a series of placebo-controlled clinical studies using once-daily doses of indacaterol ranging from 25 to 2000 µg. The duration of action of indacaterol was found to be largely independent of dose, with superior bronchodilation to placebo demonstrated at 24 hours after a single dose.