FDA reviewers: Boehringer's olodaterol provides 'modest' benefit

FDA reviewers said Striverdi Respimat olodaterol from Boehringer Ingelheim GmbH (Ingelheim, Germany) provides a "relatively modest" effect on bronchodilation in patients with chronic obstructive pulmonary disease (COPD), but questioned whether the efficacy in patients on background therapy was "clinically meaningful." The reviewers noted that pivotal trials for other COPD drugs did not include background therapy with other COPD medications. The comments came in briefing documents released ahead of the Jan. 29 meeting of the Pulmonary Allergy Drugs Advisory Committee to discuss an NDA from Boehringer for the once-daily long-acting beta 2 agonist (LABA) delivered by an inhaler. The company has not disclosed when the NDA was submitted or the PDUFA date for olodaterol, which is under review to treat airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.

The reviewers said they have no major safety concerns about use of olodaterol in COPD patients, and that in about 700 asthma patients there were no asthma-related deaths or increase in asthma-related serious adverse events. ...