(Adds background, comment from trial investigator)
By Aakash B
July 24 (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)
Glaxosmithkline (GSK)
Astrazeneca (AZN)
