Boehringer Ingelheim applies for EU approval of new COPD drug

Boehringer Ingelheim has filed marketing authorisation applications in 31 European countries for a promising new chronic obstructive pulmonary disease (COPD) therapy.

The company is seeking approval for a once-daily fixed-dose combination of tiotropium and olodaterol, delivered via the Respimat Soft Mist Inhaler as a maintenance bronchodilator treatment for COPD patients.

Tiotropium, marketed under the brand name Spiriva, has been proven to consistently reduce the risk of COPD exacerbations, while providing long-term quality of life benefits and a favourable impact on survival. Meanwhile, olodaterol – also known as Striverdi – was specifically designed as a combination partner to tiotropium.

Boehringer Ingelheim is evaluating the new combination in the phase III TOviTO clinical trial programme, which involves more than 8,000 patients and has already generated encouraging data.

Professor Klaus Dugi, chief medical officer at Boehringer Ingelheim, said: "We believe it will make an important contribution to addressing the current unmet needs of the millions of patients whose ability to lead a full life is disrupted by COPD."

This comes after the company received European approval last month for its drug Pradaxa to be used in the treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism.