Sep. 10, 2020: “The FDA has approved a new indication for GlaxoSmithKline and Innoviva’s 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).
INVAÂ +11%Â after-hours, trading at $11.72.”
https://seekingalpha.com/news/3612760-fda-oks-expanded-use-of-glaxos-trelegy-ellipta-in-asthma
