FDA panel backs long-acting Boehringer inhaler
WASHINGTON - A panel of federal health experts is overwhelmingly recommending approval for a long-acting inhaler to treat people suffering from chronic lung disease.
The Food and Drug Administration panel voted 15 to one that Boehringer Ingelheim's once-daily 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 called olodaterol with labeling that it increased patients' ability to exercise. If approved, the drug would be the first inhaler with that claim.