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

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.