(Alliance News) - GlaxoSmithKline PLC said Wednesday the US Food & Drug Administration has approved a new indication of Trelegy Ellipta for the treatment of asthma, in addition to its use in patients with chronic obstructive pulmonary disease.
The announcement was made alongside Nasdaq-listed healthcare-focused asset management firm Innoviva Inc.
Trelegy Ellipta is a combination of three molecules in a single inhaler that needs to be taken once a day. The inhaler contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2-adrenergic agonist.
The approval was based on a supplemental new drug application, which featured data from the Captain study, which showed that in patients uncontrolled on ICS/LABA inhalers, the additional bronchodilation provided by Trelegy provided significant improvements in lung function compared to FF/VI.
"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," said Chief Scientific Officer Hal Barron.
Shares in GlaxoSmithKline closed 2.7% higher at 1,532.60 pence on Wednesday in London.
By Dayo Laniyan; dayolaniyan@alliancenews.com
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