GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. The latest indication for the inhaler marks the first time a once-daily single inhaler triple therapy approved for both the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The latest approval for Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) was supported by data from the late-stage CAPTAIN study, a randomized, double-blind, global multicentre study conducted in adults aged 18 and older whose asthma was inadequately controlled despite treatment with ICS/LABA maintenance asthma medication. Trelegy Ellipta was first approved as a maintenance treatment for COPD in 2017. The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the United States.
Trelegy Ellipta contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler. The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. There is an additional strength for asthma alone which is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg.
“Millions of asthma patients in the U.S. 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,” Hal Barron, GSK’s president and chief scientific officer said in a statement.
It is estimated that approximately 30% of the 20 million people in the United States who have asthma still have breathing issues despite taking maintenance therapy medications prescribed by their doctors. GSK believes the triple-combination medication will provide a new paradigm in treatment for those patients.
“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 for appropriate patients, Trelegy Ellipta will now be available as a new treatment option,” Tonya Winders, president of the Global Allergy and Airways Patient Platform said in a statement.
Pavel Raifeld, chief executive officer of Innoviva, GSK’s partner for Trelegy Ellipta, said the approval from the U.S. Food and Drug Administration for the latest indication is a testament to the dedication the two companies have in treating respiratory diseases like asthma and COPD.
The approval announcement marks GSK’s sixth major medicine approval in 2020 across areas of significant unmet medical need including cancer, HIV, respiratory and chronic kidney disease.