US FDA backs approval of GSK's Arnuity Ellipta for asthma
UK pharma giant GlaxoSmithKline (LSE: GSK) revealed late yesterday that the US Food and Drug Administration has approved its 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. The product 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, the company noted.
Darrell Baker, senior vice president and head of GSK’s 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 USA and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients."
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