GSK announced the approval in a London Stock Exchange (LSE) filing yesterday, telling investors Trelegy Ellipta is first once-daily product approved in the US that combines three active molecules in a single inhaler.
The announcement came days after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the product be approved for moderate to severe chronic obstructive pulmonary disease (COPD).
The active pharmaceutical ingredients (APIs) in Trelegy Ellipta are: the corticosteroid fluticasone furoate; the long-acting muscarinic antagonist umeclidinium; and the long-acting beta2-adrenergic agonist vilanterol.
All three ingredients are produced at GSK’s plant in Jurong, Singapore.
The actives are delivered using the Ellipta drug powder inhaler, which was developed by US-based Innoviva Inc. The technology is used in a number of products in GSK’s respiratory disease franchise, including Anoro, Incruse and Revlar.
The finished Trelegy Ellipta inhalers are produced at GSK’s facility in Ware, Hertfordshire in the UK according to Anna Gibbins, head of communications for GSK’s respiratory franchise.
In July last year, GSK said it would spend £74m ($99m) at the site to increase Ellipta production capacity.