Striverdi Respimat olodaterol regulatory update
FDA's Pulmonary-Allergy Drugs Advisory Committee voted 15-1, with 1 abstention, that Boehringer had provided sufficient efficacy and safety data to support approval of once-daily olodaterol as maintenance therapy for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The panel also voted 15-1, with 1 abstention, in 2 separate votes that Boehringer had provided sufficient evidence of olodaterol's efficacy and safety.
On a non-voting question related to Boehringer's proposal to add exercise tolerance claims to olodaterol's prospective label, the panel commended the company for being the first to seek the claims but felt a more standardized regulatory pathway must first be established. In briefing documents released ahead of the meeting, FDA reviewers noted that there are no currently approved COPD products in the U.S. with an exercise claim and that there is no established regulatory pathway for the claim. ...