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FDA Approves Trelegy Ellipta for COPD

First once-daily, single-inhaler triple therapy for the disease in the U.S.

The FDA has approved the once-daily, single-inhaler triple therapy of fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta, GlaxoSmithKline/Innoviva, Inc.) for the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). This includes patients with chronic bronchitis and/or emphysema who are on a fixed-dose combination of fluticasone furoate (FF) and vilanterol (VI) for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired, as well as patients who are already receiving umeclidinium (UMEC) and a fixed-dose combination of FF and VI.

Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.

Trelegy Ellipta is a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist, delivered once daily in GlaxoSmithKline’s Ellipta dry powder inhaler. It is the first once-daily product approved in the U.S. that combines three active molecules in a single inhaler for the maintenance treatment of appropriate patients with COPD. The FDA-approved strength is FF/UMEC/VI 100/62.5/25 mcg.

Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the European Union, Australia, and Canada.

Source: GlaxoSmithKline; September 18, 2017.

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