FDA approves COPD drug

The U.S. Food and Drug Administration (FDA) has approved an inhalation spray, olodaterol (Striverdi Respimat, Ingelheim Pharmaceuticals), to treat people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

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

The drug is a long-acting beta-adrenergic agonist (LABA) that is designed to relax the muscles around the airways in the lungs, to prevent symptoms. It can be used only once daily over a long period of time.

The inhalation spray carries a black box warning that LABAs increase the risk of asthma-related death. The drug should not be used to treat sudden breathing problems (acute bronchospasm), nor should it be used in those with acutely deteriorating COPD. Possible side effects include narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects, but the most common side effects are runny nose, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain and joint pain.

Last month, the Centers for Disease Control and Prevention released data indicating that, in 2010, the total national medical costs attributable to COPD were about $32.1 billion annually. Of that amount, 18 percent was paid for by private insurance, 51 percent was paid by Medicare and 25 percent was by Medicaid. The study also projected an increase in COPD-related medical costs to $49 billion by 2020.

Topics: Regulatory Compliance