WASHINGTON, Nov 4 (Reuters) - GlaxoSmithKline Plc won U.S. regulatory approval for its drug Nucala to treat severe asthma, the Food and Drug Administration said on Wednesday.
The drug, Nucala, known also as mepolizumab, was approved for use in combination with other therapies for patients 12 and older who have a history of severe asthma attacks.
“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” Dr. Badrul Chowdhury, director of the FDA’s pulmonary, allergy and rheumatology products division, said in a statement.
Nucala is administered once every four weeks by injection. The drug is a monoclonal antibody that reduces asthma attacks by lowering the levels of blood eosinophils, a type of white blood cell that contributes to asthma.
About 26 million people in the United States suffer from asthma, GSK said, and up to 10 percent suffer from severe asthma. (Reporting by Toni Clarke in Washington; Editing by Ken Wills)