FDA approves Arnuity Ellipta for asthma

FDA has approved fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) for maintenance treatment of asthma in patients aged 12 years and older.

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Asthma is a chronic lung disease causing inflammation and narrowing of the airways. There are approximately 26 million people with asthma in the United States today. The causes of asthma are not completely understood, but key risk factors include inhaled substances that provoke an allergic reaction or irritate the airways. Despite medical advances, most patients suffering from asthma continue to experience poor control and significant symptoms.

Arnuity Ellipta is a once-daily inhaled corticosteroid used as prophylactic therapy for asthma. The drug acts as an anti-inflammatory to block the allergic response to allergens. The approved doses of Arnuity are 100 µg and 200 µg once daily and the drug is administered via the dry powder inhaler called Ellipta, which is used in several other approved GlaxoSmithKline products. Arnuity Ellipta should not be used for the relief of acute asthma symptoms.

According to GlaxoSmithKline, the safety and efficacy of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma. The most common adverse effects reported include upper respiratory tract infection, nasopharyngitis, headache and bronchitis. Arnuity Ellipta is contraindicated for the primary treatment of acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or other ingredients of Arnuity Ellipta. As with other oral inhalers, fungal infections of the mouth and throat may develop in patients using Arnuity Ellipta.

Full prescribing information will be available soon at us.gsk.com.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.