FDA to review new drug application for Spiriva Respimat for asthma

Boehringer Ingelheim Pharmaceuticals announced that the FDA has agreed to review its new drug application for tiotropium bromide inhalation spray for long-term maintenance of patients aged 12 years and older with asthma, according to a press release.

Tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim), a long-acting muscarinic antagonist, was approved by the FDA for the treatment of COPD in September. As maintenance treatment for COPD, tiotropium bromide inhalation powder (Spiriva HandiHaler, Boehringer Ingelheim) has been available in the US for more than 10 years, the release said.

Sabine Luik

“Boehinger Ingelheim is committed to addressing the unmet needs of patients with a variety of respiratory conditions,” Sabine Luik, MD, senior vice president, medicine and regulatory affairs, Boehringer Ingelheim Pharmaceuticals, said in the release.

The new drug application was based on data from phase 3 clinical trial programs, which evaluated tiotropium delivered through a Respimat inhaler as a once-daily, add-on treatment for adolescents and adults with moderate to severe asthma who continue to experience symptoms despite maintenance with at least inhaled corticosteroids, according to the release. The studies included more than 6,000 patients in more than 150 global sites.

A pre-measured amount of medicine is delivered through the Respimat inhaler in a slow-moving mist that helps patients inhale the medicine, regardless of how rapidly air is inhaled from the unit, the release said.

Pharyngitis, cough, dry mouth and sinusitis were the most common adverse reactions reported with Spiriva Respimat, according to the release.