Glaxo's Triple Therapy COPD Inhaler Gets Marketing Nod In EU

GlaxoSmithKline plc (NYSE:GSK) and partner Innoviva, Inc. (NASDAQ:INVA) announced that their triple combination therapy was granted marketing authorization in the EU as maintenance therapy for the treatment of patients with chronic obstructive pulmonary disease (COPD).

The once-daily single inhaler triple therapy will be marketed by the trade name of Trelegy Ellipta. It is approved for the treatment of moderate-to-severe 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 was approved in the United States in September this year. The EU approval was expected. This is because the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had granted a positive opinion recommending marketing approval of Trelegy Ellipta in September.

Trelegy Ellipta, a combination of fluticasone furoate – an ICS, umeclidinium – a long-acting muscarinic antagonist (LAMA) and vilanterol – a LABA therapy, will provide patients with a convenient dosing option by removing the need for multiple inhalers. The product is expected to bring in blockbuster sales. Trelegy Ellipta will be delivered in Glaxo’s Ellipta dry powder inhaler.

Glaxo’s shares have declined 8.6% this year so far, underperforming the 14.7% increase witnessed by the industry.

Please note that shares of Theravance Biopharma, Inc. (NASDAQ:TBPH) were up more than 6% on Thursday as the biotech has an economic interest on the royalties that Glaxo will pay to Innoviva on global sales of Trelegy Ellipta.

Glaxo has a Zacks Rank #3 (Hold).

A better-ranked stock in the large-cap pharma sector is Johnson & Johnson (NYSE:JNJ) with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of J&J are up 20.5% so far this year while earnings estimates for 2018 have gone up by almost 1% over the past 30 days.

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