GSK gets EU go-ahead for triple therapy inhaler in COPD

pharmafile | November 16, 2017 | News story | Sales and Marketing |  COPD, FDA, GSK, Trelegy Ellipta, pharma 

The EMA has awarded EU marketing authorisation to GlaxoSmithKline and Innovia’s single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema, it has emerged.

The treatment has been given the go-ahead specifically in 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 those who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

A combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist, the approval makes Trelegy Ellipta the first approved treatment of its kind to combine three active molecules in the treatment of COPD.

“COPD is a progressive disease that can worsen over time, and represents a significant burden to patients and healthcare systems,” commented Eric Dube, Senior Vice President & Head of GSK’s Global Respiratory Franchise. “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.”

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

Matt Fellows