Advertisement Boehringer's Striverdi Respimat inhalation spray gets FDA approval for COPD treatment - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Boehringer’s Striverdi Respimat inhalation spray gets FDA approval for COPD treatment

Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Striverdi Respimat (olodaterol) Inhalation Spray 5mcg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Striverdi Respimat, a long-acting beta agonist (LABA) delivered via a propellant-free inhaler, is not indicated for the treatment of acute deteriorations of COPD and also for asthma.

The approval is based on data from the Phase III olodaterol clinical trial program including data from 48-week and 6-week duration trials that showed improvements in lung function provided by the once-daily dosing of olodaterol 5mcg, as measured by forced expiratory volume in one second (FEV1), in patients with moderate to very severe COPD compared to placebo.

More than 4,900 people living with COPD were involved in the olodaterol Phase III clinical trial program.

Boehringer Ingelheim Pharmaceuticals senior vice-president of Medicine & Regulatory Affairs Sabine Luik said the approval of Striverdi Respimat marks another step forward for the company’s diverse respiratory pipeline that includes other compounds being evaluated using the Respimat inhaler.

"Boehringer Ingelheim has been a leading provider of treatments for people living with COPD for more than a decade, and we are continuing to investigate therapies that may provide additional benefits, including a Phase III program evaluating a fixed-dose combination of olodaterol and tiotropium," Luik said.