Boehringer Ingelheim is close to getting a licence for its chronic obstructive pulmonary disease blockbuster Spiriva as a treatment for asthma.
The company has announced that the indication for Spiriva (tiotropium) delivered using the Respimat device in asthma has been accepted by the regulatory authorities in the European Union, having already got the green light in Chile, Colombia, Ecuador, Norway, Russia and Thailand. It is indicated as an add-on maintenance bronchodilator treatment in adults with asthma who are currently treated with the maintenance combination of inhaled corticosteroids and long-acting beta2-agonists and who experienced one or more severe exacerbations in the previous year.
The new indication for Spiriva Respimat is based on the UniTinA-asthma Phase III programme, from which new data has been presented at the European Respiratory Society meeting in Munich. It showed that patients on Spiriva Respimat as an add-on to ICS/LABA maintenance therapy were 68% more likely to improve asthma control compared to usual care alone.
The results added to previous data showing that the drug reduced the risk of patients having a severe asthma exacerbation by a fifth and their asthma worsening by 31%.
Commenting on the results, David Halpin of the Royal Devon & Exeter Hospital, noted that despite taking current treatment options, “almost half of those with asthma still experience symptoms which can put them at a significantly increased risk of an asthma attack”. He added that “over the past decade, not much has changed in the range of therapies that we can offer patients so this new indication for Spiriva Respimat is an important and welcome advance”.
Spiriva Respimat is expected to get its licence in the UK in the next couple of weeks. Prof Halpin told PharmaTimes about a cost effectiveness analysis that came up with a quality-adjusted life year (QALY) of around £20,000, well within National Institute for Health and Care Excellence thresholds; the cost watchdog has chosen not to review it.
Patent protection on tiotropium will start running out in 2016 so the pressure is on Boehringer to get marketing fast. Prof Halpin believes it will be a success, benefitting from the proven safety and efficacy of the compound in COPD; indeed there has been much off-label use for asthma for years.
He also told PharmaTimes that he is impressed with the Respimat soft mist device, noting its superior performance over conventional dry powder inhalers.