Product Details
Identified using Sosei’s proprietary search technologies, NVA237 is a long acting bronchodilator for the treatment of chronic obstructive pulmonary disease (More about COPD).
NVA237 is the anti-muscarinic agent glycopyrronium bromide which is currently registered for intravenous use during surgery. Sosei recognised its potential as a bronchodilator through research which confirmed NVA237 has a high affinity for M1 and M3 muscarinic receptor sub-types responsible for cholinergic bronchoconstriction and mucus secretion in the lung.Worldwide, exclusive rights to NVA237 were granted to Novartis in April 2005.
Data from the Phase III studies GLOW 1 and GLOW 3 showed that NVA237 provides superior bronchodilation and increases exercise endurance relative to placebo. Data from GLOW2 study showed that NVA237 provided superior 24-hour bronchodilation compared to placebo and similar efficacy to OL tiotropium at 12 weeks.
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GLOW1
The GLOW1 study met its primary endpoint by showing that glycopyrronium 50 mcg once-daily produced a significant improvement in lung function after 12 weeks in patients with moderate-to-severe COPD compared to placebo （p<0.001). Moreover, glycopyrronium had a rapid onset of action compared to placebo at five minutes post-dose following the first dose on the first day of treatment （p<0.001）
glycopyrronium also significantly prolonged the time to first moderate/severe COPD exacerbation compared to placebo, and reduced the percentage of associated hospitalizations. Significant improvement in breathlessness was seen at 26 weeks compared to placebo, accompanied by a significant improvement in health-related quality of life and reduction in the use of rescue medication. -
GLOW2
GLOW2 met its primary endpoint by demonstrating glycopyrronium provided superior 24-hour bronchodilation compared to placebo at 12 weeks. In addition, glycopyrronium showed similar efficacy to OL tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). -
GLOW 3
The GLOW3 study investigated the effects of glycopyrronium 50 mcg once-daily on exercise endurance in moderate-to-severe COPD patients. The study met its primary endpoint by showing a significant 21% improvement in exercise endurance versus placebo at the end of the study (i.e. day 21). -
GLOW 4
GLOW4 was a 52-week study in a Japanese population that examined the safety profile of glycopyrronium using OL tiotropium 18 mcg administered in the Handihaler® device as an active control. The data from this study showed that glycopyrronium had a similar safety profile to OL tiotropium. In all studies, glycopyrronium was shown to have an overall safety profile similar to placebo. -
GLOW 5
GLOW 5 met its primary endpoint and demonstrated the non-inferiority of glycopyrronium 50 mcg once-daily compared to tiotropium 18 mcg once-daily as measured by trough FEV1 at 12 weeks. GLOW 5 was a 12-week blinded, double-dummy study and included moderate-to-severe COPD patients. -
GLOW 6
GLOW 6 met its primary endpoint and demonstrated the superiority of treating moderate-to-severe COPD patients with both glycopyrronium 50 mcg and indacaterol 150 mcg administered once-daily, versus treating patients with indacaterol 150 mcg alone as measured by trough FEV1 at week 12. The results of the study demonstrated that combining once-daily bronchodilators of two different classes resulted in a statistically significant improvement in FEV1 and a statistically significant reduction in dyspnea, or shortness of breath.
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In September 2012, NVA237 granted the approval in Japan under the brand name Seebri® Inhalation Capsules 50mcg, and in Europe under the brand name Seebri® Breezhaler® as once-daily maintenance treatment for COPD. The product has since been launched in a number of countries including Germany, UK, Japan, Denmark, and approvals have also been granted in nine other countries including Canada and Australia. In the US, filing is expected in Q1 2014.
Novartis has developed NVA237 as a once-daily monotherapy for COPD and as a fixed-dose combination with indacaterol (LABA), QVA149.
About COPD
COPD is a chronic obstruction of the airways which in the developed world is caused primarily by smoking. Symptoms include chronic bronchitis and/or emphysema which slowly progress and eventually lead to a largely irreversible loss of lung function. Worldwide, COPD is estimated to affect a total of 210 million people and is projected to become the third leading cause of death by 2020.
Market Overview
COPD is a large and fast expanding market which is estimated to be worth around $9 billion (2008) and is expected to reach $11 billion by 2014 as a result of better recognition of the disease and improved treatment options.
