The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's 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.
Asthma is a chronic lung disease that inflames and narrows the airways. Approximately 26 million people in the USA currently have asthma. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.
The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.