Regulatory Affairs

GSK, Innoviva get FDA nod for COPD treatment Trelegy Ellipta

PBR Staff Writer Published 20 September 2017

GlaxoSmithKline (GSK) and Innoviva have secured approval from the US Food and Drug Administration (FDA) for once-daily and single inhaler triple therapy, Trelegy Ellipta, to treat patients with chronic obstructive pulmonary disease (COPD).

The FDA has approved fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or Trelegy Ellipta as a long-term, once-daily and maintenance treatment for patients with COPD, including chronic bronchitis and emphysema.

Trelegy Ellipta can be used for COPD patients who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

It combines inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA), which can be delivered by using GSK’s Ellipta dry powder inhaler.

The firms have also submitted regulatory applications for Trelegy Ellipta in multiple countries, including the European Union, Australia and Canada.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has also recommended FF/UMEC/VI for approval as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

GSK global respiratory franchise SVP and head Eric Dube said: “COPD is a progressive disease that can worsen over time, and represents a significant burden to patients and healthcare systems.

“The approval of Trelegy Ellipta, and the addition of a once-daily single inhaler triple therapy to our portfolio of respiratory medicines, is an important milestone for GSK that builds on our long heritage in this area.”

Innoviva CEO Mike Aguiar said: “Trelegy Ellipta is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”