GSK’s Trelegy is indicated as a maintenance treatment for asthma and COPD. Credit: Cinerama14.

GlaxoSmithKline (GSK) and Innoviva have received the US Food and Drug Administration (FDA) approval for Trelegy Ellipta to treat asthma patients aged 18 years and older.

Trelegy Ellipta comprises a combination of fluticasone furoate, umeclidinium and vilanterol (FF / UMEC / VI) in a single inhaler.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Fluticasone furoate is an inhaled corticosteroid, while umeclidinium is a long-acting muscarinic antagonist and vilanterol a long-acting beta2-adrenergic agonist.

The drug combination is already indicated for treating chronic obstructive pulmonary disease (COPD) in the US.

The FDA approved the use of fluticasone furoate / umeclidinium / vilanterol at 100mcg / 62.5mcg / 25mcg strength for COPD and asthma, as well as 200mcg / 62.5mcg / 25mcg for asthma patients alone.

Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of asthma and also COPD, available for once-daily inhalation in the US via GSK dry powder inhaler Ellipta.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

As a maintenance treatment, the drug could help nearly 30% of adult asthma patients who experience symptoms even after adhering to inhaled corticosteroids /  long-acting beta-agonist (ICS / LABA) combination therapy.

GSK chief scientific officer and R&D president Dr Hal Barron said: “Millions of asthma patients in the US rely on multiple inhalers to help control their condition and manage their symptoms.

“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.”

FDA approval comes from results of the CAPTAIN clinical trial, where patients uncontrolled on ICS / LABA experienced improvements in lung function with Trelegy, compared to FF / VI.

CAPTAIN, a randomised, double-blind, active-controlled, six-arm parallel-group, global multi-centre trial, assessed 100mcg / 62.5mcg / 25mcg, 200mcg / 62.5mcg / 25mcg, 100mcg / 31.25mcg / 25mcg and 200mcg / 31.25mcg / 25mcg strengths of FF / UMEC / VI.

Last month, the FDA approved GSK’s Blenrep (belantamab mafodotin-blmf) as monotherapy to treat relapsed or refractory multiple myeloma.

Blenrep is the first anti-B-cell maturation antigen (BCMA) drug approved globally.