Posted by Michael Wonder on 16 Sep 2017
Trelegy Ellipta once-daily single inhaler triple therapy receives positive opinion from the CHMP in Europe for appropriate patients with COPD
15 September 2017 - GlaxoSmithKline and Innoviva today announced that the EMA 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 who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
The proposed brand name is Trelegy Ellipta.
Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the US, Australia and Canada.
