Novartis receives positive CHMP opinionto treat COPD patients in EU 

(MENAFN Press) COPD patients in Phase III GLOW trials experienced improved lung function, reduced shortness of breath, reduced exacerbations, and improved quality of life[1],[2],[3],[4]
GLOW2 study showed Seebri Breezhaler provided 24-hour bronchodilation and was superior to placebo and similar to open-label tiotropium in improving lung function[2]

Seebri Breezhaler is the latest innovation in the Novartis COPD portfolio and when approved will offer patients an alternative once-daily choice of LAMA therapy
Dubai, United Arab Emirates: Novartis has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Seebri Breezhaler (glycopyrronium/NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Seebri Breezhaler is a long-acting muscarinic antagonist (LAMA), a type of bronchodilator that is recommended in COPD global treatment strategies as maintenance therapy administered either alone or in combination with other treatments[5].

"This positive opinion for Seebri Breezhaler 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 1,996 COPD patients from around the world with many in EU countries[1],[2],[3],[4],[6].

GLOW1 demonstrated the clinically significant superiority of Seebri versus placebo for lung function improvements at 12 weeks measured by trough FEV1 (p<0.01)[1]. 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[2]. In addition to demonstrating benefits in terms of lung function, Seebri Breezhaler exhibited a rapid onset of action within five minutes at first dose[2] and reduced exacerbations[4]. 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[3].

The GLOW3 study showed that after Seebri Breezhaler was administered in the morning, patients experienced improved exercise tolerance from the first dose onward[6]. 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)[6].
In all studies, Seebri Breezhaler was well tolerated with an incidence of adverse events similar to placebo[1],[2],[3],[4],[6].

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.