Novartis announced Thursday positive results from clinical trial programs involving indacaterol/glycopyrronium (QVA149) and glycopyrronium/bromide (NVA237). Providing the pharmaceutical company with much-needed support as it submits New Drug Applications to the U.S. Food and Drug Administration for long-term treatment against chronic obstructive pulmonary disease.
Symptoms of COPD have a negative impact on a patient's ability to breathe as well as perform day-to-day activities, resulting in reduced quality of life. With many patients still experiencing symptoms despite available treatments, there was an urgent need for new COPD therapies, prompting Novartis' NDAs.
The EXPEDITION Program was carried out for QVA149, with FLIGHT 1, 2 and 3 studies done to assess the safety, efficacy and tolerability of the medication in patients with moderate-to-severe COPD. The GEM studies 1 and 2, on the other hand, were set to determine safety, efficacy and tolerability of NVA237 in patients with moderate-to-severe COPD patients. FLIGHT 1 and 2 and GEM 1 and 2 studies ran for 12 weeks while FLIGHT 3 continued for 52 weeks.
All the studies met their objectives, with QVA149 and NVA237 demonstrating significant improvements in lung function in subjects at week 12. QVA149 performed better than NVA237 and placebo while NVA237 involved side effects comparable to placebo.
"These data once again confirm the strong efficacy and favourable safety profiles of both QVA149 and NVA237. With submissions to the US FDA now complete for both treatments, we are closer to offering US patients with COPD a broader range of treatment options to help improve the significant burden of reduced lung function, and to help improve their lives," said Vasant Narasimhan, global development head for Novartis Pharmaceuticals.
Both maintenance bronchodilator treatments, QVA149 and NVA237 are only being submitted for registration in the U.S. Outside of the country, the medications are marketed as Ultibro Breezhaler 110/mcg and Seebri Breezhaler 50 mcg, respectively. QVA149 is a once-daily approved for use in more than 50 countries, including Australia, Switzerland, Japan and Canada. NVA237, on the other hand, is a twice-daily approved for use in more than 70 countries, including countries in Latin America and the European Union.
According to estimates by the World Health Organization, 210 million people all over the world have COPD. Should underlying risks factors remain unaddressed, deaths due to the condition will rise by over 30 percent over the next decade. In the U.S., COPD is the third leading cause of death, claiming 134,676 lives in 2010.
