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2020-09-13| Trials & Approvals

GSK’s Trelegy Brings Relief to Millions Suffering from Asthma

by Ruchi Jhonsa
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Asthma is a chronic pulmonary disease that affects millions of people worldwide. In the last few years, significant medical improvements have been made in the field. Despite strict adherence to medications, 30% of adult patients continue to suffer and experience poor control of asthma symptoms.

By Ruchi Jhonsa, Ph.D.

Now, a medicine developed by GSK would provide relief to these people. GSK’s inhaler Trelegy, a combination of three drugs, including a steroid, a muscarinic antagonist, and beta2-adrenergic agonist, got the USFDA approval on September 9th. The approval makes Trelegy the first single inhaler triple therapy for maintenance treatment of both asthma and COPD as well as the only therapy for patients, which needs to be inhaled once a day for relief. The strength of the medicine approved for the indication is fluticasone furoate/umeclidinium/vilanterol 100/62.5/25mcg. But, a higher strength of the medication is also available for asthma patients only that contain a two-fold higher dose of corticosteroid.

Tonya Winders, President, Global Allergy and Airways Patient Platform (GAAPP) commented: “In the US there are almost 20 million adults living with asthma and we know that many of those continue to live with and adapt their lives around ongoing symptoms, despite taking medication as prescribed by their physician. We welcome the news that Trelegy Ellipta will now be available as a new treatment option for appropriate patients.”

Related Article: GSK Reports Positive Results for Nucala in Patients with Nasal Polyps

The FDA approval is based on the findings from phase 3 CAPTAIN randomized, double-blind, global study whose results were presented at the European Respiratory Society (ERS) Congress this week. The trial showed that Trelegy surpassed GSK’s Relvar/Breao Ellipta at improving lung function after 24 weeks in patients with uncontrolled asthma. Relvar is GSK’s dual drug combination similar to Trelegy in composition except for one compound, umeclidinium. However, Trelegy failed to show significant improvement in the annual incidence of asthmatic episodes over Relvar and will not be recommended to patients for acute bronchospasm.

This medication is a relief for “million of asthma patients who rely on multiple inhalers to help control their condition” said Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK. “Today’s approval is an important advance for these patients as it allows them to benefit from triple therapy by using one inhaler, once-a-day.”

Pavel Raifeld, Chief Executive Officer of Innoviva, said: “In 2017, Trelegy Ellipta was approved in the US as the first once-daily single inhaler triple therapy for the treatment of COPD, and it remains the market leader with continued strong growth. Today’s asthma approval is another successful outcome for our long-standing partnership with GSK and a testament to our commitment to make innovative medicines accessible to patients with respiratory diseases.”

Related Article: GSK’s Trelegy Ellipta, an Advanced Treatment for Asthma & COPD Submitted for EU Approval

Reference:

1. https://www.gsk.com/en-gb/media/press-releases/fda-approves-trelegy-ellipta-as-the-first-once-daily-single-inhaler-triple-therapy-for-the-treatment-of-both-asthma-and-copd-in-the-us/

2. https://www.gsk.com/en-gb/media/press-releases/phase-iii-captain-study-of-trelegy-ellipta-in-patients-with-asthma-meets-primary-endpoint/

 

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