Trelegy Approval Boosts GSK's US Respiratory Business But Pressure Remains

With the FDA approval of Trelegy Ellipta, GlaxoSmithKline will enjoy first-to-market status with a LABA/LAMA/ICS triple combination therapy to treat COPD in the US. However, it faces the challenge of convincing payers.

Conceptual image of green tree shaped like human lungs
Trelegy is the lone COPD triple therapy in the US...for now

GlaxoSmithKline PLC has become the first company to win approval for a triple combination therapy to treat chronic obstructive pulmonary disease (COPD) in the US. The FDA has approved once-daily Trelegy Ellipta two months ahead of its expected user fee date of Nov. 21, 2017, giving it first-to-market advantage in the biggest market for COPD treatments. Trelegy comprises the inhaled corticosteroid (ICS) fluticasone furoate, the long-acting muscarinic antagonist (LAMA) umeclidinium, and the long-acting beta2-adrenergic agonist (LABA) vilanterol dosed once daily in the Ellipta dry powder inhaler,

The impending launch of Trelegy Ellipta, coming after "the confirmed success" of dual therapy Relvar/Breo Ellipta [fluticasone furoate and vilanterol]...

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