Once-Daily COPD Triple Therapy Gets FDA Approval

The FDA has approved fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta), a once-daily, single-inhaler triple therapy for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

The triple therapy, abbreviated FF/UMEC/VI, is manufactured by GlaxoSmithKline. It is specifically approved for patients with COPD including chronic bronchitis and/or emphysema who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations, who need additional treatment of airflow obstructions, or for patients who already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

The triple therapy FF/UMEC/VI is approved in a strength of 100/62.5/25 mg. It is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), delivered once-daily via a dry powder inhaler. According to a GlaxoSmithKline statement, it is the first once-daily therapy approved in the US that combines 3 active molecules in a single inhaler for the maintenance treatment of patients with COPD.

“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta. Trelegey Ellipta is the latest development in our collaboration with GSK and is testament to our ongoing efforts sto advance respiratory medicine,” said Miek Aguiar, CEO of Innoviva, Inc, the company that controls the molecular aspect of the drug.

The triple therapy is now approved in the US, but is still undergoing regulatory review in Europe. The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for FF/UMEC/VI on September 15.