FDA nod follows CHMP recommendation for first COPD triple therapy

19 September 2017

Just days after receiving a positive committee recommendation setting it up for approval in Europe, the first once-daily product that combines three active molecules in a single inhaler as a maintenance treatment for appropriate patients with chronic obstructive pulmonary disease (COPD), has been given the nod by the US regulator.

UK drug major GlaxoSmithKline (LSE: GSK) and its US partner Innoviva (Nasdaq: INVA) have achieved this milestone with their combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), to be marketed under the brand name Trelegy Ellipta.

"The addition of a once-daily single inhaler triple therapy to our portfolio of respiratory medicines, is an important milestone for GSK"

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