Novartis has filed for marketing authorization with the European Medicines Agency of its investigational drug, NVA237 (glycopyrronium bromide), the drug company announced at the European Respiratory Society in Amsterdam, The Netherlands.
Novartis has filed for marketing authorization with the European Medicines Agency of its investigational drug, NVA237 (glycopyrronium bromide) under the brand-name Seebri Breezhaler, the drug company announced as it presented a collection of data at the European Respiratory Society (ERS) in Amsterdam, The Netherlands.
In the GLOW1 study, patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) treated with NVA237 50 µg once-daily had a significant improvement in lung function after 12 weeks compared with placebo (P<.001). The drug induced a 93-mL improvement in FEV1 compared to placebo within 5 minutes of the first dose (P<.001), the company reported. NVA237 also significantly prolonged the time to first moderate/severe COPD exacerbation compared to placebo, and reduced the percentage of associated hospitalizations.
According to results from the GLOW3 study, NVA237 50 µg once daily significantly improved exercise endurance versus placebo by the end of the study (ie, day 21), with a significant 10% increase from day 1 (both P<.001).
As the company moves toward developing a combined treatment, efficacy data also was presented for the company’s Onbrez Breezhaler (indacaterol), a long-acting beta2-agonist (LABA) approved in more than 70 countries for the maintenance treatment of COPD.
One pooled analysis showed that Onbrez Breezhaler 150 µg and 300 µg g once daily significantly improved lung function for patients with moderate or less, and severe or worse COPD at 6 months compared to placebo (P<.001). In the more severe subgroup, Onbrez Breezhaler 300 µg was significantly more effective than 150 µg in improving breathlessness compared to baseline (P<.05).
A second pooled analysis showed that Onbrez Breezhaler 150 µg and 300 µg improved lung function regardless of patients’ background use of ICS. In patients not using ICS, the improvements in lung function were 180 mL and 170 mL with Onbrez Breezhaler 150 µg and 300 µg respectively compared to placebo (P<.001).
“These results illustrate the potential benefits of NVA237 for COPD patients and are especially encouraging as we move ahead with plans to develop a fixed-dose combination with Onbrez Breezhaler, our once-daily therapy in the LABA class,” said David Epstein, division head of Novartis in a company statement. “This investigational combination of 2 bronchodilators with complementary modes of action is designed to give COPD patients access to the 2 leading classes of therapy in a single inhaler for the first time.”