Respiratory - September 2020

Respiratory - September 2020

FDA approved Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of Asthma in the US

09 Sep 2020

Trelegy Ellipta (Fluticasone furoate/umeclidinium/vilanterol, ICS/LAMA/LABA) – GlaxoSmithKline (GSK)/ Innoviva

  • FDA has approved Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol) for the treatment of Asthma in patients aged 18 years and older adding to its approved COPD indication
  • The FDA-approved strengths for both COPD and Asthma are fluticasone furoate / umeclidinium / vilanterol 100/62.5/25 mcg. There is an additional strength for Asthma alone which is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25 mcg
  • Approval was based on a supplemental NDA which included data from the CAPTAIN study showing that in patients uncontrolled on ICS/LABA, the additional bronchodilation provided by Trelegy demonstrated significant improvements in lung function compared with FF/VI, in a single daily dose in an easy-to-use inhaler
  • The results from CAPTAIN were presented at the European Respiratory Society (ERS) Congress, reinforcing the potential of once-daily single inhaler triple therapy in Asthma management

GSK’s triple therapy “Trelegy Ellipta” approved in the US as a maintenance therapy for Asthma

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CI Scientists Remarks: 

  • CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomized, double-blind, active controlled, 6-arm parallel group, global multicenter study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to patients whose Asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance Asthma medication
  • Trelegy was approved in the US in Sep 2017 as a once-daily, long-term maintenance therapy in COPD. Its approval for Asthma makes it the first single-inhaler triple therapy approved for both conditions
  • Trelegy is a major sales driver for GSK in their respiratory franchise after Nucala in Q2’20

Total respiratory Q2’20 sales

£883 million +17% AER, +16% CER

Nucala sales

£241 million +24% AER, +21% CER

Trelegy sales

£194 million +62% AER, +58% CER

  • Majority of adherent Asthma patients on ICS/LABA combination therapy still experience symptoms. Trelegy approval in Asthma will give patients with an additional option to the current treatment paradigm
  • Other key triple therapies in Asthma includes:

Product

Company

Development phase

Enerzair breezhaler

Novartis

Approved (EU)

TRIMBOW

CHIESI Farmaceutici

Phase 3

Breztri

AstraZeneca

Phase 2

– Dr. Kowndinya, CI Scientists

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