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FDA OKs expanded use of Glaxo’s Trelegy Ellipta in asthma

September 10, 2020

The FDA has approved a new indication for GlaxoSmithKline (NYSE:GSK) and Innoviva’s (NASDAQ:INVA) Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD).

The FDA-approved strength for both COPD and asthma is FF/UMEC/VI 100/62.5/25mcg. There is an additional strength for asthma alone which is 200/62.5/25mcg.

The approval means Trelegy is the first single inhaler triple therapy for the maintenance treatment of both asthma and COPD in U.S.

FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day.

The company in-licensed the product from Innoviva (formerly Theravance).

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