As expected, Boehringer Ingelheim’s chronic obstructive pulmonary disease blockbuster Spiriva has bagged a UK license and is today being launched for the treatment of asthma, becoming the first long-acting muscarinic-antagonist (LABA) approved for the condition.

The new indication allows for the use of once-daily Spiriva, delivered via the Respimat Soft Mist Inhaler (SMI), as an add-on bronchodilator treatment in adult asthma patients whose disease is not adequately controlled on maintenance therapy of an inhaled corticosteroid (ICS) and long-acting beta agonist (LABA).

The licence comes on the back of data from the PrimoTinA-asthma Phase III studies showing that, compared to adding a placebo, adding Spiriva Respimat to current therapy: cut the number of patients who had a severe asthma exacerbation (26.9% versus 32.8%); reduced the risk of a severe exacerbation by 21%; and delayed the time to first episode of asthma worsening (315 days versus 181 days).

And on the safety side, the overall incidence of adverse events was comparable between patients in treatment and control groups, with the most commonly reported adverse events in both being asthma events, decreased rate of peak expiratory flow and common cold, the firm said.

Around 4.3 million adults currently receive treatment for asthma in the UK, and there remains a misconception that patients all well controlled. But evidence suggests that 55% of patients still experience symptoms, which leaves them “at a worryingly high risk of experiencing an asthma attack,” said Brian Lipworth, Scottish Centre for Respiratory Research, Ninewells Hospital, Dundee.

Unmet need

“With such high numbers of people left vulnerable, the need for new and effective treatments is clear,” he said, noting that the new Spiriva Respimat licence “gives doctors a much needed new option to protect patients against asthma attacks, which can at best be unpleasant, and at worst, life threatening”.

The drug will not be subjected to a National Institute for Health and Care Excellence review, but David Halpin of the Royal Devon & Exeter Hospital told PharmaTimes earlier this month that a cost effectiveness analysis on the product came up with a quality-adjusted life year (QALY) of around £20,000, so well within the acceptable threshold.