24th Jul 2026 14:36
(Alliance News) - AstraZeneca PLC on Friday said Trixeo and an Enhertu combination have been recommended for approval in the EU.
The Cambridge, England-based pharmaceutical company said Trixeo has been recommended for approval in the EU, by the Committee for Medicinal Products for Human Use of the European Medicines Agency, for the maintenance treatment of asthma.
This is for patients aged 12 and older whose symptoms are not adequately controlled by a combination of a medium dose inhaled corticosteroid and long-acting beta2-agonist.
Trixeo, also known as Trixeo Aerosphere in the EU and as Breztri Aerosphere in the US, China and Japan, "is a single inhaler that combines the efficacy of ICS/LABA with a long-acting muscarinic antagonist," Astra said. It is a fixed-dose triple-combination of budesonide, glycopyrronium, and formoterol fumarate.
The CHMP's positive opinion is based on results from the Kalos and Logos phase 3 trials, "in which Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA comparators."
Astrazeneca also said that its and Daiichi Sankyo's Enhertu or trastuzumab deruxtecan, in combination with pertuzumab, has been recommended for approval by the CHMP for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
This, Astra said, is based on results from the Destiny-Breast09 phase 3 trial, which showed that Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% compared with a taxane, trastuzumab and pertuzumab combination, with median progression-free survival exceeding three years.
Median progression-free survival was 40.7 months with Enhertu in combination with pertuzumab, compared to 26.9 months with THP, the company noted.
Astrazeneca shares were flat at 12,684.00 pence in London on Friday afternoon. Daiichi Sankyo shares closed up 1.6% at JPY2,799.50 in Tokyo.
By Emma Curzon, Alliance News reporter
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