Healio: FDA panel supports approval of two-drug asthma inhaler for adults, split on adolescents
By Alexandra Todak
The FDA’s Pulmonary-Allergy Drug Advisory Committee voted 16-1 in favor of approving the fixed-dose combination of budesonide and albuterol sulfate metered dose inhaler for patients with asthma aged 18 years and older.
However, the panel was split, with an 8-9 vote, on whether the benefits of this treatment outweigh the risks for an adolescent patient population aged 12 to younger than 18 years, and they were largely unanimous in voting against its approval, with a 1-16 vote, for young children aged 4 to younger than 12 years.
The fixed-dose combination of budesonide and albuterol sulfate metered dose inhaler (Avillion, AstraZeneca), or BDA, has been submitted to FDA for review for the as-needed treatment or prevention of bronchoconstriction and to prevent asthma exacerbations among patients with asthma aged 4 years and older.
“Certainly there are differences in prevalence of different [asthma] phenotypes in adults vs. kids,” Bridgette L. Jones, MD, MSc, FAAAAI, FAAP, professor of pediatrics in the division of allergy, asthma, immunology and pediatric clinical pharmacology, toxicology and therapeutic innovation at Children’s Mercy Kansas City, who voted in support of approval for both adolescents and young children, said in the discussion ahead of the vote. “But overall if you look at asthma national guidelines, for the most part many of the treatments have consistently been very similar for children and adults. I don’t think we have any biological or scientific evidence that effective drug targets especially for ICS and short-acting beta agonists would be that dissimilar between children and adults.”
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