FDA panel backs approval of GSK asthma drug in adults

By Toni Clarke

(Reuters) - An advisory committee to the U.S. Food and Drug Administration recommended approval on Thursday of GlaxoSmithKline Plc's drug mepolizumab for severe asthma in patients aged 18 and older.

The panel voted 10 to 4 against approving it in children aged 12 to 17.

The FDA is not obliged to follow the advice of its advisory panels but typically does so. If approved, the drug would be marketed under the trade name Nucala and be the first new biologic treatment for severe asthma in more than a decade.

Mepolizumab is a monoclonal antibody that binds to interleukin-5, which promotes the growth of eosinophils that can accumulate in the lungs of patients with asthma.

The extent of these accumulations correlate with the frequency and severity of asthma exacerbations. There are currently no products designed to treat patients based on predefined eosinophil levels.

The drug is designed to be given once every four weeks by injection. GSK is testing it in other conditions, including chronic obstructive pulmonary disease.

Asthma affects more than 22 million people in the United States. Severe asthma accounts for 5 to 10% of that population, according to GSK.