FDA advisory committee backs AstraZeneca’s albuterol/budesonide for asthma

FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 in favor of the albuterol/budesonide (PT027) from AstraZeneca (Nasdaq:AZN) to treat asthma in people at least 18 years old.

The voting proposition asked whether the data supported a favorable benefit-risk assessment for various age groups.

The advisory committee did not endorse albuterol/budesonide for patients 12 to 17 years old or those 4 to 11. For the former age group, nine members voted that the data do not support a favorable benefit-risk assessment. For 4- to 11-year-olds, 16 members voted against the measure, while one voted for it.

AstraZeneca is developing PT027 in collaboration with London-based Avillion.

In the U.S., the drug candidate would be a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication.

Albuterol, also known as salbutamol, was first discovered in 1966. Albuterol is a short-acting beta2-agonist (SABA).<…

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