AstraZeneca receives EU approval for asthma treatment

Trixeo is a fixed-dose triple-combination drug (budesonide/glycopyrronium/formoterol) used as maintenence treatment for patients aged 12 or older.

The drug has formerly been approved in several countries for treatment of chronic obstructive pulmonary disease (COPD), but the EU approval of it to treat asthma is new.

Just over a year ago, the European Medicines Agency's Committee for Medicinal Products for Human Use, CMHP, evaluated Trixeo Aerosphere and recommended it for approval in the EU, which was finalized this week.

“Today’s approval in asthma builds on Trixeo’s established role in improving outcomes in patients with COPD. This means we can now bring the benefits of a single-inhaler triple-combination therapy to people aged 12 years and older in Europe whose asthma remains uncontrolled on dual inhaled therapy,” Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said.

He references how Trixeo is designed for patients who are not adequately controlled by a combination of a medium dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA).

The approval was based on the positive results from the phase III trials, in which Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA comparators. It also “demonstrated a statistically significant reduction in the annualised rate of severe asthma exacerbations versus combined ICS/LABA comparators in a broad population of patients including those with no asthma exacerbations in the previous year,” the press release from AstraZeneca states.

Trixeo is branded as Breztri in markets outside of Europe. It is currently approved in the US and Japan for treatment of asthma and is currently under review in China, as well as other countries.

Trixeo/Breztri is also approved for the treatment of COPD in adults in 90 countries worldwide including the US, EU, China and Japan.