Boehringer Ingelheim files for EU approval of asthma therapy

Boehringer Ingelheim has announced it is applying for European Medicines Agency approval of its drug tiotropium (Spiriva) Respimat in a new indication.

The company is seeking approval of the product as a therapy for asthma in adults aged 18 years and over, based on positive results from the UniTinA-asthma phase III clinical trial programme, which involved more than 4,000 patients in over 150 sites globally.

It was shown that tiotropium Respimat increased time to first severe exacerbations and initial episodes of asthma worsening in previously-treated patients.

Tiotropium is already approved for the treatment of chronic obstructive pulmonary disease (COPD), having demonstrated its efficacy in more than 190 clinical trials.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "Our extensive studies have demonstrated that tiotropium Respimat has the potential to be an effective new treatment option which can provide benefits to – and improve outcomes for – adult patients with asthma."

This comes after the company received EU approval for the product Striverdi Respimat as a therapy for COPD last month.