Hold your breath. Don't gasp. A new treatment for asthma is on the anvil -- in Europe for now.

 

AstraZeneca’s Trixeo Aerosphere has got the green signal from the European Medicines Agency, with its Committee for Medicinal Products for Human Use (CHMP) recommending its approval for maintenance treatment of asthma in people aged above 12.

 

The recommendation is based on results from the Phase III KALOS and LOGOS trials, which showed that Trixeo delivered statistically significant and clinically meaningful improvements in lung function compared with inhaled dual therapy. The decision could expand the use of Trixeo beyond its existing COPD indication in Europe.

 

Trixeo Aerosphere — a single-inhaler fixed-dose triple combination of budesonide, glycopyrronium and formoterol fumarate — combines inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) therapies in one device.

 

The CHMP’s positive opinion was supported by data from KALOS and LOGOS, two large Phase III trials involving around 4,300 patients. The studies found that Trixeo significantly improved lung function compared with ICS/LABA dual therapies and reduced the annualised rate of severe asthma exacerbations in a broad patient population, including those with no exacerbations in the previous year.

 

Alberto Papi, primary investigator, said: “Across Europe, millions of people with asthma still experience reduced lung function, breathing difficulties, exacerbations and significant disruption to daily life due to uncontrolled disease. 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.”

 

The recommendation comes as healthcare systems continue to face the challenge of uncontrolled asthma, with many patients experiencing persistent symptoms despite existing treatments.

 

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Building on the recent FDA approval for Breztri/Trixeo in asthma, we are pleased by the positive CHMP recommendation, which underscores the potential of this fixed-dose triple-combination therapy to improve outcomes for patients in Europe who continue to experience uncontrolled disease. 

 

"The continued momentum of Trixeo across both asthma and COPD reflects our ambition to help transform respiratory care by delivering meaningful improvements in treatment outcomes by reducing the risk of exacerbations for patients.”

 

In addition to improving lung function, Trixeo demonstrated a rapid onset of action, showing significant improvement from baseline within five minutes after the first dose in a key secondary endpoint.