The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 10-3 to approve Boehringer Ingelheim’s Spiriva Respimat tiotropium soft mist inhaler for the treatment of COPD. BI’s first NDA submission for tiotropium Respimat took place in 2007.
Numerous safety questions about tiotropium have been raised over the years, and a briefing document for the PADAC meeting noted that, “While the discussion will include efficacy, including the COPD exacerbation claim, the focus of the meeting will be on safety and whether the submitted data support the safety of Spiriva Respimat.”
Boehringer Ingelheim Pharmaceuticals Senior VP Medicine & Regulatory Affairs Sabine Luik commented, “We are pleased with the endorsement from PADAC members, and recommendation of approval for tiotropium Respimat in the US. At Boehringer Ingelheim, we have been committed to discovering and developing new treatments to help people affected by COPD for several decades. If approved, tiotropium Respimat would build upon our heritage in treating respiratory diseases by equipping healthcare providers and their patients with an important new treatment option.”
Read the BI press release.
