AstraZeneca's inhaled asthma therapy gets FDA panel nod for use in adults but not for kids
Fotonen

A committee of the U.S. Food and Drug Administration (FDA) recommended the approval of AstraZeneca's (NASDAQ:AZN) inhaled asthma therapy PT027 in people aged 18 years and older but stopped short of giving it a greenlight for use in children and adolescents.
The British pharma giant said that the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 that the data support a favorable benefit risk assessment for the use of PT027 (albuterol/budesonide) to treat asthma in people aged 18 years and older.
In adolescents aged 12 to 17 years, the panel voted 9 to 8 that the data do not support a favorable benefit risk assessment and in children aged 4 to 11 years, the committee voted 16 to 1 that the data do not support a favorable benefit risk assessment for use of PT027 to treat asthma.
AstraZeneca noted that PT027 is a potential first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication in the U.S. containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS).
PT027 is being developed by AstraZeneca and Avillion.
The FDA had accepted a new drug application (NDA) for PT027 and is expected to make a decision in H1 of 2023.
The NDA was backed by data from the phase 3 trials, dubbed MANDALA, DENALI and TYREE.
The company reported full results from the MANDALA study in May which showed that compared with albuterol rescue, PT027 at 180-mcg albuterol/160-mcg budesonide dose reduced the risk of a severe exacerbation by 27% in adults and adolescents.
"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," said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca.