FDA panel gives nod to mepolizumab for severe asthma in adults
Author and Disclosure Information
AT AN FDA ADVISORY COMMITTEE MEETING
The number of deaths was balanced across treatment arms, though a larger number of respiratory-related deaths than expected was seen overall. This higher number of deaths may reflect the severity of asthma in the study population. The respiratory-related serious adverse events, according to the FDA, favor treatment over placebo.
No treatment-related cardiovascular risks were identified.
The FDA usually follows the recommendations of its advisory panels. The FDA panelists reported no relevant conflicts of interest.