Advisors to the US Food and Drug Administration has recommended approval of Boehringer Ingelheim’s chronic obstructive pulmonary disease drug olodaterol.
The agency’s Pulmonary-Allergy Drugs Advisory Committee voted 15-1 on both the safer and efficacy of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. If approved by the FDA, the drug will be marketed as Striverdi Respimat.
The committee reviewed data from a Phase III programme which showed that olodaterol 5mcg improved lung function in patients with moderate to very severe COPD compared to placebo and also active comparators. Full results from the studies will be presented at a future medical meeting.
Tunde Otulana, head of clinical development and medical affairs, respiratory, at Boehringer’s US unit, said the positive vote from the committee “marks an important step towards making olodaterol available to the approximately 24 million patients with COPD in the USA”. The company also highlighted studies evaluating the impact of the drug on exercise tolerance in COPD patients, but a number of panel members expressed concern about including that data on the product’s label.
More interestingly, Boehringer is working on a once-daily combination of olodaterol, a long-acting beta2 agonist (LABA), and its COPD blockbuster Spiriva (tiotropium), a long-acting muscarinic antagonist (LAMA).
