Boehringer Ingelheim announced that an expanded indication for SPIRIVA Respimat (tiotropium Respimat) as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the past year, has been accepted by the regulatory authorities in the EU.
“Almost 1 in 2 people with asthma of all ages continue to experience symptoms despite their existing treatment. Asthma symptoms significantly impact daily life including education, work, school, social lives and sleep,” said Professor Eckard Hamelmann, Head of the Paediatric Department, Children’s Center Bethel in Bielefeld, Germany. “This new approval, supported by extensive data from the UniTinA-asthma clinical trial programme, recognises the benefit tiotropium Respimat® add-on therapy can bring to adolescents and children with asthma as young as 6 years old.”
Tiotropium Respimat is part of a class of medicines called long-acting muscarinic antagonists (LAMA) and is the only one of its kind approved for asthma. It works differently from other treatment options by complementing other maintenance therapies (usually ICS/LABA‡) to improve lung function, improve symptom control and reduce the risk of exacerbations or asthma attacks. The safety profile of tiotropium Respimat across all age groups is comparable to placebo.
The expanded indication following finalisation of the decentralised European regulatory procedure on 9 March 2018 is supported by the completion of the large scale UniTinA-asthma clinical trial programme. This demonstrated that tiotropium Respimat add-on therapy is effective and well tolerated in asthma patients as young as 6 years old.
“Boehringer Ingelheim is committed to improving the lives of people with respiratory disease,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Respiratory, Boehringer Ingelheim. “Asthma symptoms impact all areas of patients’ lives, often leaving them feeling a sense of confinement, their daily activities defined by their disease. We believe that the expanded EU indication for tiotropium Respimat will bring benefit to more people with symptomatic asthma aged 6 years and above.”
Tiotropium is delivered via Respimat, the only inhaler that actively delivers a unique mist, meaning patients only need a minimal inhalation effort for the medication to go deep into the lungs. It can be inhaled successfully and without help by the majority of children aged 6 years and above.
Tiotropium Respimat was previously approved for use in the EU as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 µg budesonide/day or equivalent) and long-acting beta2-agonists and who experienced one or more severe exacerbations in the previous year.
Filed Under: Drug Discovery