GlaxoSmithKline clears another regulatory hurdle with new COPD treatment

GlaxoSmithKline, along with Innoviva, announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/ umeclidinium/vilanterol as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

The FTSE 100 drugmaker said the proposed brand name is Trelegy Ellipta.

It described Trelegy Ellipta as a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist, delivered once daily in GSK's Ellipta dry powder inhaler.

GSK said it is the first once-daily single inhaler triple therapy to be granted a positive opinion by the CHMP, with the proposed strength being FF/UMEC/VI 100/62.5/25 mcg.

“We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers,” said GSK’s president of research and development Patrick Vallance.

Mike Aguiar, CEO of Innoviva, said the positive opinion would lead to a “significant” therapeutic convenience for those appropriate patients already on ICS/LABA treatment that require additional bronchodilation.

“Trelegy is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, the companies explained.

A final decision by the European Commission is anticipated by around the end of 2017.

Regulatory applications had been submitted and were undergoing assessment in a number of other countries, including the US, Australia and Canada.

GSK and Innoviva said Trelegy Ellipta remained an investigational medicine not yet approved for use as a single inhaler triple therapy anywhere in the world, with the proposed trade name subject to regulatory approval.