FDA Approves Boehringer Ingelheim’s COPD Drug Striverdi RespimatBy
The US Food and Drug Administration has approved Boehringer Ingelheim’s Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time. Striverdi Respimat is not intended to be used in patients with acutely deteriorating COPD, according to an FDA press release reporting on the approval.
Striverdi Respimat is a long-acting beta-adrenergic agonist (LABA) that helps the muscles around the airways in the lungs stay relaxed to prevent symptoms. It is approved for use in the treatment of COPD in Canada, Russia, the United Kingdom, Denmark, and Iceland.
Boehringer Ingelheim is also studying olodaterol as a possible future combination partner with the company’s Spiriva (tiotropium bromide inhalation powder), the company’s long-acting muscarinic antagonist (LAMA) for treating COPD. In May 2014, the company reported positive Phase III results of a once-daily fixed-dose combination of tiotropium and olodaterol.
Both olodaterol as a monotherapy and the fixed-dose combination of tiotropium and olodaterol are delivered using Boehringer Ingelheim’s Respimat SoftMist Inhaler. Respimat is an inhaler delivering a slow-moving “soft mist” that is designed to allow gentle inhalation to make it easier for patients to take their therapy. In 2013, Boehringer Ingelheim increased production capacity for the Respimat inhaler at its facilities in Dortmund and Ingelheim, Germany, at a cost of EUR 57 million ($76 million), according to the company’s 2013 earnings release of April 15, 2014.
Source: FDA and Boehringer Ingelheim