May 22 (Reuters) - The U.S. Food and Drug Administration
has approved British drugmaker GSK's asthma drug to
treat some patients with a chronic lung disease commonly known
as "smoker's lung", the company said on Thursday.
The approval expands the use of the drug, Nucala, as an
add-on treatment for patients with a type of chronic obstructive
pulmonary disease.
Sanofi and Regeneron's blockbuster drug
Dupixent and Verona Pharma's inhaled therapy Ohtuvayre
are also approved for the condition, which affects the lungs,
causing restricted airflow and breathing problems.
GSK's Nucala is a monoclonal antibody that inhibits
interleukin-5, which helps regulate eosinophils, a type of white
blood cell that causes inflammation in the lungs when
overproduced.
The regulator had set a target action date of May 7 for its
decision on the drug. The approval, however, came two weeks
later.
This is the latest instance where the drug regulator has
missed its deadline after mass layoffs as part of a major
overhaul of federal health agencies under Secretary of Health
and Human Services Robert F. Kennedy Jr.
The approval was based on a late-stage trial, in which
patients treated with Nucala and an inhaled maintenance therapy
for up to 104 weeks had significantly reduced exacerbations by
21% compared to placebo.
"There's a very high burden when you have severe
exacerbations and end up being hospitalized. The aim is to keep
patients out of the hospital, keep them stable, and keep them at
home," GSK's Chief Commercial Officer Luke Miels said ahead of
the approval.
Nucala recorded 1.78 billion pounds ($2.38 billion) in total
sales last year.
The disease commonly affects cigarette smokers but can also
be caused by air pollution and related occupational hazards. It
is the fourth leading cause of death worldwide, according to the
World Health Organization.