FDA Approves Boehringer Ingelheim's Striverdi Respimat For COPD

Boehringer Ingelheim announced in a press release that the Food and Drug Administration (FDA) has approved Striverdi Respimat (olodaterol) for the treatment of chronic obstructive pulmonary disease (COPD). The medication is delivered via a propellant-free inhaler for long-term airflow obstruction treatment. The FDA based its approval in part on Phase III studies of 5,000 people who were permitted to keep taking their other prescriptions such as anticholinergics, short-acting beta agonists, inhaled corticosteroids, and xanthines.

Sabine Luik, SVP of Medicine & Regulatory Affairs at Boehringer Ingelheim, said, "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."

Striverdi Respimat

Striverdi Respimat is a bronchodilator treatment system for patients with COPD including chronic bronchitis and/or emphysema. It does not treat acute deteriorations of COPD nor does it treat asthma. The drug is a long-acting beta agonist (LABA) dispensed at 5mcg once daily, which helps the muscles in the airway stay relaxed.

Richard Casaburi, MD, PhD, of the Harbor-UCLA Medical Center, said that since many patients are on more than one type of medication to improve airflow, the FDA approval of olodaterol is important as it works in combination with some medications, excluding long-acting beta-adrenergic agonist (LABAs).

Boehringer supported its application with Phase III trials that showed an improvement in lung function, as measured by forced expiratory volume in one second (FEV1). The FDA said in its press release that COPD is the third leading cause of death in the United States. The agency said that safety and effectiveness of Striverdi Respimat for COPD is proven, but it is not proven for asthma and people should not use it for rescue therapy to treat sudden breathing problems (acute bronchospasm). The side effects of the drug include paradoxical bronchospasm, runny nose, upper respiratory tract infection, bronchitis, and urinary tract infection among others.

Boehringer Ingelheim Respiratory Treatments

Headquartered in Ingelheim, Germany, Boehringer Ingelheim has been developing drugs for respiratory diseases and conditions for almost one hundred years. The family-owned company earned 14.7 billion euros in sales in 2012, of which pharmaceuticals contributed 23 percent. In July, the company announced another win for a respiratory drug: the FDA granted Breakthrough Therapy designation to nintedanib for treatment of idiopathic pulmonary fibrosis (IPF), a fatal lung disease.