Novartis has filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for its NVA237 glycopyrronium bromide dry powder inhaler, which will be called the Seebri Breezhaler. The MAA once-daily long-acting antimuscarinic (LAMA) triggered a $5 million milestone payment to Sosei, which co-developed the product with Vectura and licensed it to Novartis in 2005.
At the 2011 European Respiratory Society (ERS) congress, Novartis presented additional Phase 3 data from the GLOW1 and GLOW3 studies of NVA237 in COPD demonstrating that the drug produced a significant in lung function versus placebo from the first dose and improved exercise endurance.
Sosei CEO Shinichi Tamura elaborated on future plans for NVA237: “The filing of this product originating from Sosei and Vectura is an important milestone for us and is further endorsement of our capabilities. The NVA237 Phase III data at ERS illustrate the potential benefits of NVA237 for patients with COPD; a multi-billion dollar market that is still growing. Novartis has a rich portfolio of once-daily inhaled therapies to help COPD patients and has stated that it expects to file QVA149, the fixed-dose combination of NVA237 and their once-daily LABA, indacaterol, in 2012. The combination of two bronchodilators with complementary modes of action is designed to give COPD patients access to two leading classes of therapy in a single inhaler for the first time.”
Novartis Division Head David Epstein also commented on that path, saying, “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.”
Read the Sosei press release.
Read the Novartis press release.
