FDA Approves New Lung Disease Medication

Striverdi Respimat for COPD receives FDA approval

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication for chronic obstructive pulmonary disease (COPD).

The FDA announced its approval of Boehringer Ingelheim's COPD medication known as Striverdi Respimat (olodaterol).

COPD is a general term used to describe lung diseases like chronic bronchitis and emphysema.

Striverdi Respimat is part of a class of medications designed to relax the muscles around the airways of the lungs, thus reducing symptoms of COPD.

"Ask your pulmonologist about emerging treatments for your lung disease."

The FDA approval of Striverdi Respimat comes after researchers tested the medication's safety and effectiveness on more than 3,000 people. According to an FDA press statement, patients who received Striverdi Respimat showed better lung function than those who received placebo (fake medication).

"The availability of this new long-term maintenance medication provides an additional treatment option for the millions of Americans who suffer with COPD," said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation.

The National Heart, Lung and Blood Institute reports that COPD is the third leading cause of death in the US. The main cause of COPD is smoking.

Striverdi Respimat is part of a class of medications known as long-acting beta-adrenergic agonists (LABAs). The newly approved medication carries a boxed warning that LABAs raise the risk for asthma-related death. Striverdi Respimat is not approved to treat asthma, as its safety and effectiveness have not been tested in asthma patients.

The FDA warns that Striverdi Respimat should not be used as a rescue therapy for sudden breathing problems. The agency also said the medication should not be used in those with quickly worsening COPD.

Review Date: 
July 31, 2014
Last Updated:
August 1, 2014