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FDA panel gives nod to mepolizumab for severe asthma in adults

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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.