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 The panel voted 10 to 4 against approving it in children aged 12 to
17.
The FDA is not obliged to follow the advice of its advisory panels
but typically does so. If approved, the drug would be marketed under
the trade name Nucala and be the first new biologic treatment for
severe asthma in more than a decade.
Asthma affects more than 22 million people in the United States.
Severe asthma accounts for 5 to 10 percent of that population,
according to GSK.
Mepolizumab is a monoclonal antibody that binds to a receptor known
as interleukin-5 which promotes the growth of eosinophils. These are
certain type of white blood cell that can accumulate in the lungs of
patients with asthma.
The extent of these accumulations correlate with the frequency and
severity of asthma exacerbations. There are currently no products
designed to treat patients based on predefined eosinophil levels.
The drug is designed to be given once every four weeks by injection.
GSK is testing it in other conditions, including chronic obstructive
pulmonary disease, a respiratory disorder often associated with
smoking.
[to top of second column] |
(Reporting by Toni Clarke in Washington; Editing by Eric Beech and
Cynthia Osterman)
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