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AstraZeneca asthma drug meets targets in phase 3 trials

ALN

AstraZeneca PLC on Friday reported that its triple-combination asthma treatment Breztri Aerosphere met all primary endpoints in two late-stage clinical trials, raising the potential to improve treatment options for patients whose condition is not controlled by current therapies.

The Cambridge, England-based pharmaceutical company said its Kalos and Logos phase 3 trials showed Breztri achieved statistically significant and clinically meaningful improvements in lung function compared with dual-combination inhaled corticosteroid and long-acting beta2-agonist therapies.

The replicate trials evaluated Breztri - a fixed-dose inhaled combination of budesonide, glycopyrronium and formoterol fumarate - in over 4,400 patients with uncontrolled asthma.

No new safety concerns were identified in the trials, AstraZeneca said.

Breztri, already approved in more than 80 countries for the treatment of chronic obstructive pulmonary disease, could now expand its reach to asthma patients. The company said it would present the full results to regulators and at an upcoming medical meeting.

Sharon Barr, executive vice president of BioPharmaceuticals R&D at AstraZeneca said: ‘These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients.’

Asthma affects around 262 million people globally. Nearly half of those treated with dual therapies remain uncontrolled, which can lead to persistent symptoms and reduced quality of life.

Shares in AstraZeneca were up 0.3% at 10,641.40 pence in London on Friday morning.

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