20 August 2014 -- GlaxoSmithKline plc today announced that the Food
and Drug Administration has approved Arnuity™ Ellipta® (fluticasone
furoate inhalation powder), a once-daily inhaled corticosteroid (ICS)
medicine for maintenance treatment of asthma as prophylactic therapy in
patients aged 12 years and older. Arnuity is not indicated for relief of
acute bronchospasm.
The
approved doses are Arnuity Ellipta 100mcg and 200mcg. Arnuity Ellipta
is administered once daily via the dry powder inhaler called Ellipta,
which is also used across a range of other approved respiratory
medicines in the GSK portfolio.
Darrell Baker, Senior Vice President & Head, GSK Global
Respiratory Franchise, said, “The approval of Arnuity Ellipta is an
important development for GSK and our expanding respiratory portfolio.
It is the first asthma treatment from our new portfolio to have gained
approval in the US and enables us to begin expanding the range of
medicines that we offer to physicians and appropriate patients.”
The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma.
Arnuity and Ellipta are trademarks of the GlaxoSmithKline group of companies.
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