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Glaxo/Innoviva's Trelegy Ellipta Gets FDA Nod for Asthma

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GlaxoSmithKline plc GSK and partner Innoviva, Inc. INVA announced that the FDA has granted approval to its medicine Trelegy Ellipta for a new asthma indication. The FDA has approved the triple combination once-daily single inhaler as a maintenance treatment of asthma in patients aged 18 years and older who are not adequately treated by a combination of ICS and a LABA.

At present, Trelegy Ellipta, a triple combination therapy of inhaled corticosteroid (“ICS”)/LAMA/LABA (fluticasone furoate/umeclidinium/vilanterol 'FF/UMEC/VI'), is approved to treat chronic obstructive pulmonary disease (“COPD”)

With the approval for the asthma indication, Trelegy becomes the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD.

The supplemental new drug application seeking approval for the asthma indication was based on data from the phase III CAPTAIN study, which evaluated Trelegy Ellipta versus Relvar/Breo Ellipta (FF/VI). Data from the study showed that treatment with Trelegy Ellipta led to statistically significant improvement in lung function in asthma patients compared with Relvar/Breo.

GlaxoSmithKline’s shares have declined 15.4% so far this year compared with 0.9% decrease of the industry during the period.


Trelegy Ellipta brought in sales of £387 in the first half of 2020, recording growth of 85% at constant exchange rate.

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

We remind investors that AstraZeneca’s AZN triple combination therapy Breztri Aerosphere/PT010 was approved for the treatment of COPD in July.

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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AstraZeneca PLC (AZN) : Free Stock Analysis Report
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Innoviva, Inc. (INVA) : Free Stock Analysis Report
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