FDA Panel Backs Long-Acting Boehringer Inhaler
A panel of federal health experts on Tuesday overwhelmingly recommended approval for a long-acting inhaler to treat people suffering from chronic lung disease.
The Food and Drug Administration panel voted 15-1, with one abstention, that Boehringer Ingelheim's once-daily Striverdi Respimat (STRIH-ver-dee Res-peh-mat) inhaler is safe and effective for chronic obstructive pulmonary disease, a condition that causes bronchitis and emphysema.
The disease affects about 24 million people in the U.S. and is most commonly caused by cigarette smoking. Symptoms include cough, phlegm and shortness of breath.
The FDA is not required to follow the guidance of its panels, though it often does.
German drugmaker Boehringer is also asking the agency to approve the drug, known chemically as olodaterol, with labeling stating that it increased patients' ability to exercise. If approved, the drug would be the first inhaler with that claim.
Boehringer studied the drug in patients for up to 48 weeks, measuring their lung capacity based on volume of air they could expel.
"The positive vote from the advisory committee marks an important step towards making olodaterol available," said Boehringer vice president Tunde Otulana in a statement.