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Glaxo's Triple Therapy COPD Inhaler Gets CHMP Nod in the EU

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GlaxoSmithKline plc (GSK - Free Report) and partner Innoviva, Inc. (INVA - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion recommending approval of its once-daily single inhaler triple therapy in the EU.

So far this year, Glaxo’ share price has increased 4.5%, comparing unfavorably with a gain of 16.4% recorded by the industry it belongs to.

The once-daily single inhaler triple therapy is proposed to be called Trelegy Ellipta. Glaxo is looking to get Trelegy Ellipta approved for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD) in patients who are already being treated with a combination of inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA) but require additional bronchodilation.

Trelegy Ellipta is a combination of fluticasone furoate – an ICS, umeclidinium –   a long-acting muscarinic antagonist (LAMA) and vilanterol – a LABA therapy. Trelegy Ellipta will be delivered in Glaxo’ Ellipta dry powder inhaler.

Glaxo’s Ellipta products have been quite successful and are a key driver of the company’s sales. In the last reported quarter — second quarter of 2017 — Ellipta products recorded a 73% surge in sales, driven by market share gains and the ongoing rollout in Europe and other international markets.

Trelegy Ellipta, if approved, will be the first single inhaler triple therapy to be approved anywhere in the world. We believe the therapy will enjoy strong demand as it can remove the need for multiple inhalers for COPD patients. This can further boost sales of Glaxo’s Ellipta products.

A final decision from the European Commission is expected around the end of the year. The candidate is also under review in many countries including the United States.

Glaxo carries a Zacks Rank #3 (Hold).

Stocks to Consider

Better-ranked biotech stocks include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Alexion have gained 19.9% year to date. The Zacks Consensus Estimate for 2017 and 2018 increased 5.2% and 7.5%, respectively, over the past 60 days.

Regeneron’s shares have rallied 18.1% this year so far. Its estimates have moved up 16.7% for 2017 while that for 2018 have climbed 8.9% over the past 60 days.

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