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news.The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) fluticasone furoate inhalation powder, to be sold as Arnuity Ellipta, as a daily-once corticosteroid for treatment of asthma in patients aged above twelve years in the US.
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Fluticasone furoate inhalation powder has been approved for 100mcg and 200mcg doses. It is controlled through a dry powder inhaler called Ellipta, which has been deployed across a range of other approved respiratory medicine in GSK portfolio.
GSK Global Respiratory Franchise senior vice-president and head Darrell Baker 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."
GSK noted that the effectiveness and safety of Arnuity Ellipta had been assessed in more than 3,600 asthma patients.
Arnuity Ellipta is not designated for acute bronchospasm, while it is contraindicated for key treatment of status asthmaticus or sensitive periods of asthma necessitating intensive measures and in patients with severe hypersensitivity to milk proteins or any Arnuity Ellipta ingredients.
About 5% of the study participants reported upper respiratory tract infection, nasopharyngitis, headache and bronchitis as common adverse reactions.
Image: GlaxoSmithKline’s office in Philadelphia, US. Photo: courtesy of Beyond My Ken.