AstraZeneca has received two positive recommendations from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), bringing its new respiratory and oncology therapies a step closer to approval in the European Union
The CHMP has recommended approval of Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate) as a maintenance treatment for asthma in patients aged 12 years and older whose disease remains uncontrolled despite treatment with a medium-dose inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA).
Marketed as Breztri Aerosphere in the US, China, and Japan, the therapy combines an ICS, a LABA, and a long-acting muscarinic antagonist (LAMA) in a single inhaler.
The recommendation is supported by data from the Phase III KALOS and LOGOS trials, in which Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA therapies. A pooled analysis of the two studies also showed a significant reduction in the annual rate of severe asthma exacerbations across a broad patient population, including those without a history of exacerbations in the previous year.
“The CHMP positive opinion for Trixeo represents an important step forward, offering a potential new treatment option that could help reduce exacerbations and improve disease control for patients living with asthma independent of their prior exacerbation history,” said Alberto Papi, professor and chair of Respiratory Medicine at the University of Ferrara and primary investigator of the studies.
Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals Business Unit, said the recommendation highlights the potential of the fixed-dose triple-combination therapy to improve outcomes for patients in Europe whose asthma remains uncontrolled.
Trixeo/Breztri is already approved in the US for asthma treatment and is under regulatory review in Japan and China. It is also approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults across 90 countries, including the US, EU, China, and Japan.
AstraZeneca’s breast cancer treatment
In a separate development, the CHMP has also recommended approval of Enhertu (trastuzumab deruxtecan), developed by AstraZeneca and Daiichi Sankyo, in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer.
The recommendation is based on findings from the DESTINY-Breast09 Phase III trial, which showed that the Enhertu-pertuzumab combination reduced the risk of disease progression or death by 44% compared with a taxane, trastuzumab, and pertuzumab (THP). Median progression-free survival (PFS) was 40.7 months, compared to 26.9 months with THP.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “HER2-positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2-targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes.”
John Tsai, Global Head, R&D, Daiichi Sankyo, added, “Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2-positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.”
Enhertu plus pertuzumab is already approved in the US, Switzerland, and other countries as a first-line treatment for metastatic HER2-positive breast cancer. The therapy is also under EU review for patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant HER2-targeted treatment.
