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- Title
Olodaterol: First Global Approval.
- Authors
Gibb, Andrew; Yang, Lily P. H.
- Abstract
Olodaterol (Striverdi ® Respimat ®) is a novel, long-acting, β 2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat ® Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval have also been made in the USA, the EU and elsewhere. Phase II trials have been conducted in patients with asthma. The company is also developing a fixed-dose combination of olodaterol with tiotropium bromide, a long-acting anti-muscarinic agent, for the treatment of COPD. This article summarizes the milestones in the development of olodaterol leading to this first approval for COPD.
- Subjects
ADRENERGIC beta agonists; CLINICAL trials; OBSTRUCTIVE lung diseases; UNITED States. Food &; Drug Administration; DRUG approval; INHALATION administration; PHARMACODYNAMICS
- Publication
Drugs, 2013, Vol 73, Issue 16, p1841
- ISSN
0012-6667
- Publication type
Journal Article
- DOI
10.1007/s40265-013-0137-9