BI scores an FDA approval for mist-based COPD drug
- The FDA has now approved Spiriva (tiotropium) Respimat for the treatment of chronic obstructive pulmonary disease (COPD).
- In 2008, the FDA rejected approval of Spiriva Respimat due to safety concerns stemming from showing that it increased the risk of death by 52%.
- Safety concerns were dispelled once results from the Tiospir trial confirmed the product’s safety.
With the approval of Spiriva Respimat, COPD patients now have a choice -- dry inhaler versus mist. However, it took several years for Boehringer Ingelheim (BI) to gain approval for this version of Spiriva, which is already a blockbuster based on sales of the dry inhalation version. By enrolling more than 5,700 patients in the largest COPD trial to date, investigators were able to prove its safety and efficacy.
Convenience is a major consideration with this product. Spiriva Respimat provides a pre-measured amount of medicine in a slow-moving mist, so it doesn’t matter how rapidly or slowly a patient breathes in when taking the medication. BI is continuing to seek additional indications for Spiriva Respimat, which will soon be launched in Europe for the treatment of asthma.
- Pharma Times FDA approves BI's Spiriva Respimat for COPD