AstraZeneca/Avillion Asthma Combo Draws Split Decision At FDA Panel; Data Was ‘All Over The Place’

 
• By Sue Sutter

In near unanimous votes, advisory committee rejects budesonide/albuterol sulfate fixed-dose combination for young children but favors approval for adults; the vote in adolescents was more divided, with some panelists believing extrapolation of adult efficacy data were appropriate for this population.

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Several panelists on both sides of the vote in adolescents said they would give deference to FDA on this population in light of the agency’s past experience with extrapolating adult efficacy data. • Source: Shutterstock

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