Boehringer Ingelheim’s Spiriva looks set for more widespread use after being accepted by all national health authorities included in the EU’s decentralised procedure as a treatment for patients with poorly-controlled asthma.
Spiriva (tiotropium) is already a massive seller for chronic obstructive pulmonary disease (COPD) with sales approaching $5bn last year, but can now also be prescribed in Europe for adult patients who are having breakthrough attacks despite treatment with inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs).
The drug – which works as a muscarinic antagonist – is the first new therapeutic class to be approved for asthma in more than a decade, according to Boehringer.
Professor David Halpin, an asthma specialist at the Royal Devon & Exeter Hospital, said: “We know 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.
“These statistics clearly highlight the critical need for new and effective asthma treatments.”
Approval by the European Medicines Agency (EMA) was based on the results of a phase III trial programme – called UniTinA-asthma – that collectively showed that Spiriva reduced the risk of severe asthma exacerbations by 21% when added to background therapy and reduced the risk of worsening symptoms by 31%.
Boehringer has also presented new data at the European Respiratory Society congress in Munich this week, which found that the drug improved symptom control by 68% when added to ICS/LABA therapy.
Despite being the first new drug class for asthma in years, market research firm Datamonitor estimates that approval in asthma will provide only a marginal uptick in sales of Spiriva.
Research issued last month suggested Boehringer’s drug would add a fairly modest $250m in sales for the product in both the EU and US by 2021, in part because it will compete at the severe end of the asthma spectrum with several new biologic therapies coming through the pipeline and also because some patients may already be prescribed the drug off-label.
Datamonitor estimates that by 2021 the total asthma market will reach around $18bn, with biologics such as interleukin-5 (IL-5) inhibitors from GlaxoSmithKline (GSK), AstraZeneca (AZ) and Teva accounting for around $2.7bn of that total.