GSK Receives FDA Approval for Respiratory Drug Arnuity Ellipta

The US Food and Drug Administration has approved GlaxoSmithKline’s  (GSK) Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid 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.

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. The approved doses are Arnuity Ellipta 100 mcg and 200 mcg.

Fluticasone furoate, the active ingredient in Ellipta, is also the active ingredient in GSK’s nasal spray, Veramyst, which was approved by the FDA in 2007 to treat symptoms of seasonal and perennial allergic rhinitis in patients two years of age and older. Earlier this year, GSK received FDA approval for Breo Ellipta, a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

Source: GlaxoSmithKline

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