Spiolto Respimat is now approved in Croatia, the UK, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain.
The company said that Spiolto Respimat provides significant improvements in lung function, breathlessness, quality of life and rescue medication use over Spiriva right from the initial stages when patients need maintenance therapy.
Mainz University Hospital Professor of Medicine and Pulmonary Department head Roland Buhl said: "The additional benefits gained from Spiolto Respimat compared to Spiriva are significant for patients and data show the lung function benefits are even greater when used in the initial stages of COPD.
"Optimal management right from the start of maintenance therapy may give patients with this highly debilitating lung disease, the best opportunity to stay active, manage their symptoms and have a better quality of life."
The national regulatory approvals are based on data from the >5,000 patient Tonado I&II clinical trials, which are part of the >15,000 patient Tovito clinical trial program which shows Spiolto Respimat provides clinically relevant improvements over Spiriva.
Boehringer Ingelheim chief medical officer Klaus Dugi said: "Since its first launch in 2002, Spiriva has brought medical benefits that have made a real difference to the lives of millions of patients with COPD around the world.
"Spiolto Respimat is our newest advance in COPD treatment. Its recent approval in the US, Canada and Australia, alongside the approval in countries across Europe, is an important step forward in our ongoing commitment to provide effective solutions for patients with COPD.
"We anticipate further approvals of Spiolto Respimat in other European countries over the coming months."
Image: Boehringer Ingelheim’s corporate headquarters in Ingelheim, Germany. Photo: courtesy of Boehringer Ingelheim GmbH.