Nucala is FDA-approved as an additional severe asthma treatment

GlaxoSmithKline's drug Nucala was approved by the U.S. Food and Drug Administration (FDA) Wednesday to be used in combination with other medicines to treat severe asthma.

Also known as mepolizumab, Nucala is given as an injection once every four weeks in individuals with severe asthma attacks who are at least 12 years old and are already on an asthma medicine. It is a protein interleukin-5 (IL-5) inhibitor that works by decreasing the levels of blood eosinophils, which is a type of white blood cell that can cause asthma.

Clinical studies showed that Nucala was effective in reducing exacerbations that would require hospitalization and/or visits to the emergency room among patients with severe asthma and who were currently using available asthma therapies and medications. Additionally, those that were given the injection experienced a longer lapse in time between exacerbations and were able to reduce their daily maintenance dose of oral corticosteroid without affecting the amount of control they have on managing the chronic disease.

“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” Badrul Chowdhury, the director of the division of pulmonary, allergy and rheumatology products in the FDA's Center for Drug Evaluation and Research, said.

Asthma affects more than 22 million individuals in the United States and causes more than 400,000 hospitalizations annually.