The CHMP has adopted a positive opinion for Seebri® Breezhaler® 44mcg as a once-daily inhaled maintenance bronchodilator to relieve symptoms of chronic obstructive pulmonary disease (COPD).
The announcement from Novartis relating to glycopyrronium/NVA237 at a dose of 50mcg glycopyrronium per capsule “is a major milestone in our efforts to offer COPD patients and health care professionals an alternative once-daily therapy in the LAMA class that has the potential to reduce breathlessness, increase the capacity to exercise and help improve quality of life,” said David Epstein, Division Head of Novartis Pharmaceuticals.
“When approved, Seebri Breezhaler will be the second innovative once-daily inhaled treatment in the growing Novartis COPD portfolio delivered using the low-resistance Breezhaler device that allows patients to hear, feel and see that they have taken the drug correctly.”
Data from three of the Novartis Phase III GLOW trials informed the CHMP’s positive opinion for Seebri Breezhaler and included 1996 COPD patients from around the world with many in EU countries.
GLOW demonstrated the clinically significant superiority of Seebri versus placebo for lung function improvements at 12 weeks measured by trough FEV1 (p<0.01).
GLOW2 demonstrated a similar magnitude of effect and also showed that Seebri was similar to open-label (OL) tiotropium over 52 weeks measured by improvements in trough FEV1 compared to placebo.
In addition to demonstrating benefits in terms of lung function, Seebri Breezhaler exhibited a rapid onset of action within five minutes at first dose and reduced exacerbations.
Significant benefits in both breathlessness and health-related quality of life, as measured by the Transition Dyspnea Index (TDI) and St. George’s Respiratory Questionnaire (SGRQ) compared to placebo, were also demonstrated.
The GLOW3 study showed that after Seebri Breezhaler was administered in the morning, patients experienced improved exercise tolerance from the first dose onward.
Overall, patients treated with Seebri Breezhaler experienced a significant 21% improvement in exercise endurance versus placebo at the end of the study (day 21), with a significant 10% increase from day one (both p<0.001).
In all studies, Seebri Breezhaler was well tolerated with an incidence of adverse events similar to placebo.
The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation. Worldwide submissions and reviews of Seebri® Breezhaler® (glycopyrronium bromide/NVA237) are ongoing. The US filing for Seebri Breezhaler is expected in 2014.