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Glaxo/Innoviva File for Approval of Trelegy Ellipta in Japan

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GlaxoSmithKline plc (GSK - Free Report) and partner Innoviva, Inc. (INVA - Free Report) announced the submission of a regulatory application in Japan seeking approval for their once-daily, single inhaler triple combination therapy, Trelegy Ellipta for the treatment of chronic obstructive pulmonary disease (“COPD”) in adults.

The therapy is already approved and marketed for the treatment of COPD in the United States and Europe. Trelegy Ellipta brought in sales of £10 million in the United States and £1 million in the EU during the first quarter.

Trelegy Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid (“ICS”), umeclidinium, a long-acting muscarinic antagonist (“LAMA”) and vilanterol, a long-acting beta2-adrenergic agonist (“LABA”). The therapy will be available in a single Ellipta inhaler, the first of its kind.  Typically, the ICS/LAMA/LABA amalgamation is delivered via two or more inhalers for the treatment of COPD patients. The product is expected to bring in blockbuster sales.

GlaxoSmithKline’s shares have gained 12.1% so far this year against 4.9% decline of the industry during the period.

The filing included data from the Phase III IMPACT study, evaluating the safety and effectiveness of Trelegy Ellipta in comparison to existing COPD therapies. The study revealed superiority of the closed triple combination over 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.

Per the company’s press release, COPD is a progressive serious lung disease, which affects over five million patients in Japan. A potential approval by the Japanese Ministry of Health, Labour and Welfare is likely to boost the prospects of the drug.

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

Glaxo is well poised on back-to-back launch of three new products — Trelegy Ellipta, Shingrix and Juluca — and the agreement to buy out Novartis’ (NVS - Free Report) stake in the Consumer Healthcare JV.

Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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