FDA approves GlaxoSmithKline’s Arnuity Ellipta for treatment of asthma
Published on August 21, 2014 at 1:58 AM
GlaxoSmithKline plc today announced that the FDA 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, SVP & 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.
Full US Prescribing Information, including Patient Information Leaflet, will be available soon at: us.gsk.com. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the "GSK Inquiries" section at the end of this document.