Novartis combo therapy for COPD shows promise in clinical trials, awaits FDA approval

Novartis ($NVS) announced that its investigational combination indacaterol/glycopyrronium bromide therapy for COPD performed better than its constituent components in a Phase III clinical trial.

The candidate (QVA149) met its clinical endpoint and demonstrated clinically meaningful improvements in lung function at 12 weeks compared to either ingredient alone or placebo, Novartis said.

The twice-a-day dual bronchodilator led to improvements in breathlessness, overall quality of life and less use of COPD rescue medication for sudden attacks. It also had a comparable safety profile to the constituent components or placebo, according to a Novartis release.

Novartis Global Head of Development Vasant Narasimhan

"These data confirm that QVA149 significantly improves lung function, breathlessness, and most importantly, overall quality of life," said Novartis Global Head of Development, Vasant Narasimhan, in a statement. "With millions of people in the US and around the world struggling to breathe due to COPD, Novartis is committed to advancing QVA149 and other new medicines to address this important unmet need".

QVA149 is marketed as the Ultibro Breezhaler outside the U.S., including the European Union, Latin America, Japan, Canada, Switzerland and Australia, where it is to be taken once a day, though it is being investigated for twice-a-day use in the U.S.

Novartis also said its twice-a-day formulation of glycopyrronium bromide has been submitted for U.S. registration following similarly positive trial results. It is marketed as Seebri Breezhaler in more than 80 countries, where it is used once a day.

Novartis says the Breezhaler inhaler has a low resistance, which makes it suitable for patients with differing severity of airflow limitation. The device ensures patients they have taken the full dose correctly, the company says.

The Swiss Big Pharma expects to hear word on FDA approval (or rejection) of the candidates in the second half of this year.

- read the release