FDA committee recommends approval of Boehringer COPD drug
- Spiriva Respimat is the mist version of the only currently FDA-approved version of Spiriva -- the Sprivia HandiHaler, a dry powder inhalation formula.
- Spiriva is used for long-term, once-daily maintenance treatment of bronchospasm due to chronic obstructive pulmonary disease (COPD).
- In extensive clinical analysis, there were no significant differences in risk of death, cardiovascular adverse events, or on-treatment, all-cause mortality between the Respimat and HandiHaler formulations of Spiriva.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10-3 in favor of approving Spiriva Respimat based on existing data that included thousands of patients. One trial included in the analysis, TIOSPIR, involved 17,000 patients and is the largest COPD trial ever conducted.
If Spiriva Respimat is approved it will most likely increase overall sales of Spiriva, a blockbuster drug that grossed $2.17 billion during the first six months of the year. In addition, it will give patients with COPD a choice between mist and dry powder inhalation delivery options.
- Pharma Times BI's Spiriva Respimat moves closer to US approval