Boehringer Ingelheim is celebrating after the US Food and Drug Administration approved the mist version of its chronic obstructive pulmonary disease blockbuster Spiriva.
The approval of Spiriva (tiotropium) delivered using the Respimat device is based on data from seven trials, notably Tiospir, which showed that it has similar safety and exacerbation efficacy to the older dry powdered form of tiotropium, Spiriva HandiHaler. Boehringer noted that Spiriva Respimat provides a pre-measured amount of medicine in a slow-moving mist that helps patients inhale the medicine "and was developed to actively deliver medication in a way that does not depend on how fast air is breathed in from the inhaler".
The FDA had previously rejected Spiriva Respimat amid safety fears raised from a meta-analysis which claimed that the latter was linked to a 52% increase in the risk of death compared to placebo. However Tiospir, the largest trial conducted to date in patients with COPD, collected data from more than 5,700 patients treated with Respimat and roughly the same number via HandiHaler and the results allayed the agency’s fears; last month, the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10-3 that existing data supported approval.
Patent protection on tiotropium will start running out in 2016 but Boehringer is confident about its future prospects in COPD. At the European Respiratory Society meeting in Munich earlier this month, positive Phase III data was presented on Spiriva, a long-acting muscarinic antagonist, combined with the company’s olodaterol, a long-acting beta agonist delivered via the Respimat inhaler.
Spiriva Respimat is also going to be rolled out in Europe soon as a treatment for asthma.