FDA Alert: Mepolizumab Approved to Treat Severe Asthma

The U.S. Food and Drug Administration (FDA) approved a novel drug targeting interleukin-5, mepolizumab (Nucala), for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Mepolizumab is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

According to MedPage Today, the agency went against one of its own advisory committees, which voted in June not to recommend the drug's approval in adolescents after determining that there was inadequate evidence of safety in this population. The committee did support approval in adults. The FDA's approval announcement does not indicate why it decided to overrule the committee on the adolescent indication.

Read the full FDA announcement here.