Novartis and UK partner Vectura are celebrating after European regulators gave the green light to Seebri Breezhaler for chronic obstructive pulmonary disease.
The European Commission has approved Seebri (glycopyrronium bromide) as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adults with COPD. The news comes a couple of days after the drug was approved in Japan.
The European approval is based on data from the Phase III GLOW trials which demonstrated the safety and efficacy of glycopyrronium 44 mcg (the Japanese thumbs-up is for 50mcg) and involved 1,996 COPD patients who required maintenance treatment. The studies showed that Seebri, when compared to placebo, significantly improved lung function over the first four hours after morning dosing and that this benefit was sustained for 24 hours over a 52-week period. The studies also showed that Seebri, a long-acting muscarinic antagonist, was similar to Boehringer Ingelheim's LAMA blockbuster Spriva (tiotropium) in improving lung function.
David Epstein, head of Novartis Pharma, said the approval of Seebri in Europe "is an exciting and critical milestone that provides physicians and patients with a new once-daily COPD therapy so they have the flexibility of having the right treatment for the right patient at the right time". The company is also developing QVA149, a fixed-dose combination of Seebri and Novartis' Onbrez Breezhaler (indacaterol), a long-acting beta 2-agonist which is expected to be filed in Europe and Japan by the end of 2012.
The approvals in Europe and Japan are good news for Vectura as they trigger a $10 million and $2.5 million milestone respectively.