Astrazeneca's Trixeo Aerosphere secures EU approval.
Drugmaker Astrazeneca said on Wednesday that its Trixeo Aerosphere candidate has been approved in the European Union as a maintenance treatment for asthma in patients aged 12 and over.
Source: Sharecast
Astrazeneca stated Trixeo was now the first and only triple‑combination therapy cleared in the EU for this age group, regardless of exacerbation history, with the single‑inhaler treatment combining an inhaled corticosteroid, a long‑acting beta2‑agonist and a long‑acting muscarinic antagonist. The drug was already marketed as Breztri Aerosphere in the US, China and Japan.
The European Commission's decision followed a positive opinion from the EMA's CHMP and was supported by results from its Phase III KALOS and LOGOS trials.
Astrazeneca said Trixeo delivered statistically significant improvements in lung function versus dual ICS/LABA comparators. In pooled analyses, it also reduced the annualised rate of severe asthma exacerbations across a broad patient population, including those without exacerbations in the prior year.
As of 1100 BST, Astrazeneca shares were down 0.96% at 12,550p.
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