In a fast-moving chronic obstructive pulmonary disease (COPD) field where triple combination therapies are driving much of the momentum, GlaxoSmithKline (LSE: GSK) has sought to widen its patient population in Europe.
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), developed by the UK drugmaker and its partner Innoviva (Nasdaq: INVA), is already approved in Europe as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-adrenergic agonist.
Now the company has submitted data to the European Medicines Agency as part of a type II variation to support an expanded label for Trelegy Ellipta, meaning it could be used by physicians to treat a wider population of patients with the condition who are at risk of an exacerbation and require triple therapy.
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