(Adds details on treatment, context and background)
Oct 1 (Reuters) - The U.S. Food and Drug Administration
declined to approve AstraZeneca Plc's combination
therapy to treat smoker's lung, the drugmaker said on Tuesday.
AstraZeneca said that it will work closely with the FDA
regarding next steps, including submitting results from an
additional late-stage study, which was not completed at the time
the marketing application was submitted to the health regulator.
The therapy, PT010, was approved in Japan in June as a
triple-combination therapy to relieve symptoms of chronic
obstructive pulmonary disease (COPD), AstraZeneca said.
Colloquially 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.
COPD is predicted to be the third leading cause of death by
2020, according to the British drugmaker.
The setback comes as AstraZeneca tries to catch up with
domestic rival GlaxoSmithKline's Trelegy, which is
delivered through inhaler Ellipta. That treatment pulled in 156
million pounds in sales last year in its use against COPD.
(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by
Bernard Orr)
Astrazeneca (AZN)
Glaxosmithkline (GSK)