BI’s COPD Drug Striverdi Respimat Gets FDA Nod
Boehringer Ingelheim’s inhalation spray Striverdi Respimat has received FDA clearance for patients with chronic obstructive pulmonary disease, including those with airflow obstruction due to chronic bronchitis or emphysema.
The approval was based on a study of 3,104 COPD patients that found the drug improved lung function in these patients. The once-daily spray, which can be used for long periods, helps muscles around the lungs’ airways to stay relaxed and prevent COPD symptoms, the FDA said.
Curtis Rosebraugh, director of the FDA’s Office of Drug Evaluation II, said the availability of Striverdi Respimat (olodaterol) provides an additional treatment option for millions of Americans who suffer with COPD, the third leading cause of death in the U.S., caused primarily by cigarette smoking.
The drug is specifically contraindicated in patients with acute lung deterioration. It also comes with a boxed warning that long-acting, beta-adrenergic agonists may increase the risk of death in patients with asthma. The FDA is requiring BI to include a patient medication guide detailing these risks.
The drug was approved in the UK, Denmark and Iceland in October. BI spokeswoman Jennifer Forsyth said that the company currently is studying the drug in combination with the once-daily long-acting anticholinergic tiotropium. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.