FDA Adcomm Backs AstraZeneca's 2-In-1 Asthma Inhaler, Only For Adults Being Less Sure For Adolescents, Kids

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  • The FDA's Pulmonary-Allergy Drugs Advisory Committee has voted 16 to 1 that the data support a favorable benefit-risk assessment for AstraZeneca Plc's AZN PT027 (albuterol/budesonide) for asthma in people aged 18 years and older. 
  • In adolescents aged 12 to 17 years, the Committee voted 9 to 8, and for children aged 4 to 11 years, the Committee voted 16 to 1 that the data do not support a favorable benefit-risk assessment for PT027 for asthma.
  • The FDA is slated to decide in the first half of 2023. 
  • PT027, an inhaler combining two existing compounds, is being positioned as a rescue treatment for asthma.
  • Among the 3,132 patients enrolled in MANDALA, there were only 100 adolescents and 83 children, precluding "meaningful statistical inference of treatment benefits," AstraZeneca wrote
  • It also noted that it lowered the enrollment target for adolescents and children in DENALI owing to "additional challenges" amid the Covid-19 pandemic.
  • Researchers deployed Bayesian modeling to extrapolate positive data for pediatric subpopulations. But the adcomm wasn't convinced.
  • Together with development partner Avillion, AstraZeneca will discuss the next steps with the FDA, "including for adolescents and children," said Mene Pangalos, AstraZeneca's EVP of biopharmaceuticals R&D.
  • Price Action: AZN shares are up 0.44% at $61.60 on the last check Wednesday.
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