- June 7, 2018
- Posted by: PharmaScroll
Boehringer Ingelheim today announced an expanded UK indication for Spiriva (tiotropium) Respimat as add-on maintenance bronchodilator treatment in patients aged six years and older with severe asthma who experienced one or more severe asthma exacerbations in the past year, following the European Union regulatory acceptance in March 2018.
The US Food and Drug Administration expanded use of Spiriva Respimat to this younger patient population in February 2017. Spiriva, Boehringer’s biggest selling product, generated revenues of 2.8 billion euros ($3.3 billion), down 3.9% year-on-year.
“Asthma is one of the most common long-term illnesses in childhood and yet there are relatively few treatments which have been proven to be of benefit in young patients,” commented Professor David Halpin, Consultant Physician at the Royal Devon and Exeter Hospital, adding: “I welcome this expanded indication for Spiriva Respimat, which is based upon robust clinical trial evidence, and which recognises the efficacy and safety of tiotropium maintenance therapy in patients as young as six years old as well as adults.”
The UK has one of the highest prevalence rates for paediatric asthma worldwide, with one in 11 children affected.It is estimated that in the UK a child is admitted to hospital every 20 minutes because of an asthma attack.
Tiotropium Respimat was previously approved 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.
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