FDA Approves New Asthma Drug for Maintenance Treatment

By Kristin J. Kelley

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA has approved mepolizumab (Nucala) for maintenance treatment of asthma. It is used in combination with other asthma medications and is indicated for patients aged 12 years and older who can't control severe asthma attacks with their current treatments.

The injectable drug — a humanized interleukin-5 antagonist monoclonal antibody produced by modifying Chinese hamster ovary cells — is administered monthly by a clinician.

In randomized trials, patients with severe asthma were given either mepolizumab or placebo as an add-on treatment every 4 weeks. Those on mepolizumab experienced a longer duration without an asthma exacerbation and fewer attacks that led to hospitalization overall than those on placebo. The drug didn't significantly improve lung function.

Back pain, headache, fatigue, and reactions at the injection site are among the drug's most common side effects. Treatment can also cause more serious adverse hypersensitivity reactions (including difficulty breathing) and herpes zoster infections.