(Reuters) - The U.S. Food and Drug Administration approved AstraZeneca’s drug to treat patients with a form of lung disease, the British drugmaker said on Friday.
The drug Breztri Aerosphere is being approved as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), the third leading cause of death globally, AstraZeneca said.
Known as “smoker’s lung”, COPD is a progressively worsening and potentially deadly condition that affects more than 380 million people worldwide, primarily caused by smoking, but also by occupational hazards such as air pollution or chemical fumes.
The approval for AstraZeneca comes at a time when the British drugmaker is seeking to catch up with the runaway success of rival Glaxosmithkline’s Trelegy Ellipta drug.
COPD-related sales of Trelegy Ellipta more than tripled to 518 million pounds last year. Trimbow by Italy’s Chiesi is another competitor in the European market.
Breztri Aerosphere, which is a three-drug inhaler, is already approved in Japan and China for patients with COPD and is under regulatory review in the European Union, AstraZeneca said.
Last month, data from a late-stage trial showed that Breztri reduced the risk of a recurrence in flare-ups, or exacerbations, by between 13% and 24% when compared to standard two-drug inhalers, and cut the risk of death from all causes by 46%.
“Preventing exacerbations is central to the management of COPD ... Breztri Aerosphere has demonstrated significant benefits in reducing exacerbations,” Weill Cornell, an investigator in a late-stage trial that tested the drug, said.
Sales of Astra’s respiratory drugs rose 10% last year, while oncology drugs saw a 44% surge in revenues.
Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Shounak Dasgupta and Catherine Evans