FDA approves GSK's Arnuity Ellipta for treating asthma

The FDA has approved fluticasone furoate inhalation powder as a once-daily corticosteroid for maintenance treatment of asthma in patients aged 12 and older, according to a press release.

Fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) is approved for 100 mcg and 200 mcg doses, according to the release. It is administered through a dry powder inhaler called Ellipta, which has been used with other GSK-approved respiratory medicines. Efficacy and safety had been evaluated in more than 3,600 patients, the release said.

“The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio,” Darrell Baker, senior vice president and head of GSK Global Respiratory Franchise, said in the release. “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.”

Arnuity Ellipta is not indicated for acute bronchospasm, the release said, adding that it is “contraindicated for primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or any ingredients of Arnuity Ellipta.”

Common adverse reactions reported in at least 5% of study participants were upper respiratory tract infection, nasopharyngitis, headache and bronchitis.

Full US prescribing information is expected to be available soon at us.gsk.com, according to the release.