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Asthma Drug Arnuity Ellipta (Fluticasone Furoate) Wins FDA Nod
The FDA has approved Arnuity Ellipta (fluticasone furoate inhalation powder, GlaxoSmithKline), a once-daily inhaled corticosteroid medication for maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older. The product is not indicated for the relief of acute bronchospasm.
The approved doses for Arnuity Ellipta are 100 mcg and 200 mcg. The treatment is administered once daily via the Ellipta dry-powder inhaler.
The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma.
Asthma is a chronic lung disease that inflames and narrows the airways. Approximately 26 million people in the U.S. have the disease. Despite medical advances, more than half of patients continue to experience poor disease 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 include inhaled substances that provoke allergic reactions or irritate the airways.
Arnuity Ellipta is contraindicated for the 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.
Candida albicans infection of the mouth and throat may occur in patients treated with Arnuity Ellipta.
Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
Source: GlaxoSmithKline; August 20, 2014.