Glaxo-Innoviva's Triple Combo Inhaler Positive In Phase III
Zacks Investment Research | Sep 20, 2017 09:44PM ET
GlaxoSmithKline plc (NYSE:GSK) and partner Innoviva, Inc. (NASDAQ:INVA) announced that its once-daily single inhaler triple therapy — Trelegy Ellipta (FF/UMEC/VI, fluticasone furoate/umeclidinium/vilanterol) — met primary endpoint in a phase III IMPACT study, showing reduction in exacerbations in patients with chronic obstructive pulmonary disease (COPD).
While fluticasone furoate is an inhaled corticosteroid (ICS), umeclidinium is a long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2-adrenergic agonist (LABA). This combination medicine will be delivered once daily in the Ellipta dry powder inhaler. Typically, the ICS/LAMA/LABA amalgamation for advanced COPD is delivered via two or more inhalers with a potentially differing dose regime. However, GlaxoSmithKline’s triple therapy combination offers a daily treatment in a single Ellipta inhaler.
Notably, this week, the triple combination therapy was approved in the United States under the brand name, Trelegy Ellipta, as maintenance therapy for treatment of patients with COPD. Last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion, recommending approval of this combination therapy in the EU.
Notably, the closed triple combination therapy is not licensed as a single inhaler triple therapy anywhere outside the United States.
GlaxoSmithKline’s shares are up 4.3% so far this year, comparing unfavorably with the 16.8% rally of the Zacks Investment Research
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