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 (NASDAQ: 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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