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FDA approves Nucala for severe asthma in adolescents, adults

The FDA approved Nucala for use with other asthma medicines for the maintenance treatment of asthma among patients aged 12 years and older.

“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

A humanized interleukin-5 antagonist monoclonal antibody, Nucala (mepolizumab, GlaxoSmithKline) is administered once every 4 weeks by subcutaneous injection by a health care professional into the upper arm, thigh or abdomen. Mepolizumab is intended to moderate severe asthma attacks by reducing the levels of blood eosinophils.

The FDA approval stems from efficacy and safety data from three double blind, randomized, placebo-controlled trials in patients with severe asthma on currently available therapies, according to the release. Mepolizumab or a placebo was administered to patients every 4 weeks as an add-on asthma treatment.

Data indicated that patients with severe asthma receiving mepolizumab exhibited fewer exacerbations requiring hospitalization and/or ED visits and experienced longer time to the first exacerbation, compared with placebo. Patients with severe asthma who were administered mepolizumab also experienced greater reductions in their daily maintenance oral corticosteroid dose, while preserving asthma control vs. patients receiving placebo.

Treatment with mepolizumab, however, did not result in a significant improvement in lung function.

Common adverse events associated with mepolizumab included headache, injection site reactions, back pain and fatigue. In addition, hypersensitivity reactions, including swelling of the face, mouth and tongue, and lightheadedness, fainting, hives, breathing and rash, were noted to occur within hours or days of treatment.

The FDA release also reported that herpes zoster infections were reported in patients receiving mepolizumab.