Novartis says that Onbrez is better at improving lung function and reducing breathlessness than one of the current mainstays of treatment for chronic obstructive pulmonary disease.
Onbrez (indacaterol), a once-daily, novel, inhaled, ultra long-acting beta-2 agonist (LABA) gave superior bronchodilation to the LABA salmeterol when compared in a 12-week randomised study in 1,123-patients aged 40 and above from seven countries with moderate to severe COPD. Bronchodilation was assessed by measuring patients’ forced expiratoryvolume of breath in one second (FEV1) from five minutes to 11 hours 45minutes post dose.
Significantly more patients had a clinically relevant improvement in breathlessness on 150ug once-daily indacaterol and less need for rescue medication compared to patients taking 50ug twice-daily salmeterol (sold by GlaxoSmithKline as Serevent).
The results from the Phase III INSIST study were presented at the European Respiratory Society meeting in Barcelona by lead investigator Stephanie Korn from the pulmonary department at Mainz University Hospital in Germany. She said: “These results confirm that indacaterol is an attractive option for maintenance treatment of COPD. Prescribers are going to find these results very interesting because they have wanted to know if indacaterol can deliver clinically meaningful benefits over and above salmeterol. This study shows that it can.”
The INSIST findings bolster the position of indacaterol as an attractive option for maintenance therapy of moderate to severe COPD compared to standard treatments. Findings from the INLIGHT-2 study, involving 1,002 patients, showed that 150ug once-daily indacaterol provided a greater improvement in lung function after 12 weeks than salmeterol 50ug twice-daily or placebo with similar safety profiles.
Onbrez is approved in more than 40 countries, including the European Union, and is indicated for the maintenance treatment of airflow obstruction in adults with COPD. The drug is not yet approved in the USA and the Food and Drug Administration has requested to review additional clinical data that Novartis plans to file by the end of this year.