At its January 29, 2013 meeting, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of the 5 µg dose of Boehringer Ingelheim’s Striverdi Respima olodaterol soft mist inhaler for the maintenance treatment of COPD.
BI VP of Clinical Development and Medical Affairs, Respiratory Tunde Otulana said, “We at Boehringer Ingelheim are pleased with the Advisory Committee’s recommendation and look forward to continuing to work with the FDA as the Agency continues its review of the olodaterol NDA. The positive vote from the Advisory Committee marks an important step towards making olodaterol available to the approximately 24 million patients with COPD in the United States.”
According to BI, the committee reviewed exercise tolerance studies in addition to safety and efficacy data, noting that the company had made the first request ever to include exercise tolerance data in the product label of a COPD drug.
Read the Boehringer Ingelheim press release.
