AstraZeneca, the FTSE 100 pharmaceuticals group, has secured European approval for its inhaler Trixeo as a maintenance treatment for asthma.
The company said it was the first and only triple-combination therapy cleared in the European Union for asthma patients aged 12 and over, regardless of their history of flare-ups.
Trixeo, sold as Breztri in the US, China and Japan, combines three drugs in a single inhaler to open the airways and reduce inflammation.
It is approved for patients whose asthma is not adequately controlled by a standard two-drug inhaled therapy.
The green light from the European Commission followed a positive opinion from the region's medicines regulator, based on results from two late-stage trials known as KALOS and LOGOS.
In those studies, involving around 4,300 patients, Trixeo delivered statistically significant improvements in lung function against two-drug comparators.
A pooled analysis also showed a significant reduction in the rate of severe asthma attacks.
The approval extends the reach of a product already established in treating chronic obstructive pulmonary disease, or COPD, where it was prescribed to more than 6.8 million patients last year.
AstraZeneca pointed to a sizeable market opportunity, noting that nearly 43 million people in Europe live with asthma, with about four million newly diagnosed each year.
Around half of patients remain uncontrolled on dual therapies, the company said.
Ruud Dobber, president of AstraZeneca's biopharmaceuticals unit, said the approval would bring the benefits of a single-inhaler triple therapy to more patients across Europe.
Respiratory and immunology is one of the company's main therapy areas and a key driver of growth.
