FDA committee votes in favour of AstraZeneca asthma candidate

The FTSE 100 pharmaceuticals giant said the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted that data supported a “favourable” benefit-risk assessment for the use of PT027, or albuterol-budesonide, for the treatment of asthma in people aged 18 years and older.

In adolescents aged 12 to 17 years, the committee voted nine-to-eight that the data did not support a favourable benefit-risk assessment, and in children aged four-to-11 years, it voted 16-to-one that the data did not support a favourable assessment for the use of PT027.

It described PT027 as a potential first-in-class, pressurised metered-dose inhaler fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid.

The treatment was being developed by AstraZeneca and Avillion.

In the first half of 2022, the FDA accepted the new drug application (NDA) for PT027, and set a Prescription Drug User Fee Act date for the first half of 2023.

“We are pleased that the Pulmonary-Allergy Drugs Advisory Committee has recognised the potential for PT027 to deliver important benefits for people with asthma, as a first-in-class treatment option in the US,” said Mene Pangalos, executive vice-president of biopharmaceuticals research and development.

“We look forward to working with our partner Avillion and the FDA to progress the application and discuss next steps, including for adolescents and children.”

At 1008 GMT, shares in AstraZeneca were up 0.54% at 10,718p.

Reporting by Josh White for Sharecast.com.