FDA Approves GSK’s Drug Arnuity Ellipta to Treat Asthma in the US

FDA Approves GSK’s Drug Arnuity Ellipta to Treat Asthma in the US

GlaxoSmithkline LogoThe U.S. Food and Drug Administration recently approved GlaxoSmithKline‘s treatment of asthma, Arnuity Ellipta (fluticasone furoate inhalation powder), as a prophylactic therapy in patients aged 12 years and older. Arnuity Ellipta is a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment as a prophylactic therapy and is not indicated for relief of acute bronchospasm.

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

GlaxoSmithKline tested Arnuity Ellipta in more than 3,600 patients with asthma in order to assess the efficacy and safety of the drug, which is indicated to be used in doses of 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta.

Asthma is a chronic lung disease that inflames and narrows the airways, and affects about 26 million people in the United States. Despite being treated medically, more than half of patients still experience poor control and significant symptoms. It is not known what causes the disease, however, researchers relate it with an interaction between the patient’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

GlaxoSmithKline is not only committed to finding a more efficient treatment for asthma, but also for other lung diseases, such as chronic obstructive pulmonary disease (COPD). The company also recently announced positive results of a Phase 3 trial that tested the novel drug Incruse Ellipta as a combined treatment for COPD.

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