Glaxo/Innoviva's Trelegy Ellipta Gets Line Extension In Europe

GlaxoSmithKline plc (NYSE:GSK) and partner Innoviva, Inc. (NASDAQ:INVA) announced the approval of label expansion of chronic obstructive pulmonary disease (“COPD”) drug, Trelegy Ellipta, in Europe. The drug is now approved as a maintenance treatment in a broader moderate-to-severe COPD patient population those who are not adequately treated by a long-acting muscarinic antagonist (“LAMA”) and long-acting beta2-agonist (“LABA”) or dual bronchodilation.

Trelegy Ellipta, a triple combination therapy of inhaled corticosteroid (“ICS”)/LAMA/LABA (fluticasone furoate/umeclidinium/vilanterol 'FF/UMEC/VI'), is already approved as maintenance treatment for COPD patients who are not adequately treated by a combination of ICS and a LABA.

The label expansion was approved based on data from phase III IMPACT study, which showed that the closed triple combination, Trelegy Ellipta, is superior to ICS-LABA combination, Relvar/Breo Ellipta, and LAMA-LABA combination, Anoro Ellipta, in improving lung function and health-related quality of life, and reducing exacerbations in COPD patients. A similar label update was approved by the FDA in April.

GlaxoSmithKline’s shares have gained 15.7% so far this year compared with 8% increase of the industry during the period.

Trelegy Ellipta brought in sales of £32 million in the United States and £9 million in the EU during the third quarter. Trelegy Ellipta benefited from share gains following FDA approval to include IMPACT data on the U.S. label. We expect further share gains following approval in Europe.

Please note that Theravance Biopharma, Inc. (NASDAQ:TBPH) has an economic interest on the royalties that Glaxo will pay to Innoviva on global sales of Trelegy Ellipta.

Glaxo has seen strong growth momentum in its three new products — Trelegy Ellipta, Shingrix and Juluca – so far this year. Moreover, the agreement to buy out Novartis’ (NYSE:NVS) stake in the Consumer Healthcare JV has strengthened Glaxo’s competitive position.

We remind investors that AstraZeneca is also developing a triple combination therapy PT010 for the treatment of COPD.

Zacks Rank

Glaxo currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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