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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

A US Food and Drug Administration advisory committee overwhelmingly voted 8 November that adult efficacy data for Avillion LLP and AstraZeneca PLC’s novel budesonide/albuterol sulfate product could not be extrapolated to young children with asthma, but the panelists were more closely divided on the question of whether such data could support approval in adolescents.

After voting 16-1 that the data supported a favorable benefit-risk assessment for use of the fixed-dose combination of budesonide and albuterol sulfate (BDA) in asthma patients ≥18 years, the Pulmonary-Allergy...

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