Innoviva

FDA Approves Trelegy Ellipta as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Both Asthma and COPD in the US

Retrieved on: 
Wednesday, September 9, 2020
Health, FDA, Other Health, General Health, Clinical trials, Pharmaceutical, Biotechnology, Health, Drugs, Respiratory therapy, Dosage forms, Combination drugs, Muscarinic antagonists, Asthma, Ellipta, Fluticasone furoate/umeclidinium bromide/vilanterol, Inhaler, Fluticasone furoate/vilanterol, Metered-dose inhaler, asthma, the CAPTAIN Study, Trelegy Ellipta (FF/UMEC/VI) in the US, GSK, Innoviva

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 US.

Key Points: 
  • 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 US.
  • We welcome the news that for appropriate patients, Trelegy Ellipta will now be available as a new treatment option.
  • The results from CAPTAIN were presented at the European Respiratory Society (ERS) Congress this week, reinforcing the potential of once-daily single inhaler triple therapy in asthma management.
  • Trelegy Ellipta was approved in the US on 9 September 2020 for the maintenance treatment of asthma in patients aged 18 years and older.

FDA Approves Trelegy Ellipta as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Both Asthma and COPD in the US

Retrieved on: 
Wednesday, September 9, 2020
Medical Supplies, Health, FDA, Medical devices, Clinical trials, Pharmaceutical, Biotechnology, Health, Drugs, Respiratory therapy, Dosage forms, Combination drugs, Muscarinic antagonists, Asthma, Ellipta, Fluticasone furoate/umeclidinium bromide/vilanterol, Inhaler, Fluticasone furoate/vilanterol, Metered-dose inhaler, asthma, the CAPTAIN Study, Trelegy Ellipta (FF/UMEC/VI) in the US, GSK, Innoviva

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 US.

Key Points: 
  • 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 US.
  • We welcome the news that for appropriate patients, Trelegy Ellipta will now be available as a new treatment option.
  • The results from CAPTAIN were presented at the European Respiratory Society (ERS) Congress this week, reinforcing the potential of once-daily single inhaler triple therapy in asthma management.
  • Trelegy Ellipta was approved in the US on 9 September 2020 for the maintenance treatment of asthma in patients aged 18 years and older.

GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma

Retrieved on: 
Thursday, February 27, 2020
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Medical specialties, Medicine, Gut flora, Pathogenic microbes, Yeasts, Branches of biology, Ellipta, Glucocorticoids, Fluticasone furoate, Candida albicans, Cándida, Asthma, the CAPTAIN Study, Trelegy Ellipta (FF/UMEC/VI), GSK, Innoviva

Regulatory applications have also been submitted for the Trelegy duplicate licences, Elebrato Ellipta and Temybric Ellipta.

Key Points: 
  • Regulatory applications have also been submitted for the Trelegy duplicate licences, Elebrato Ellipta and Temybric Ellipta.
  • Trelegy Ellipta is not indicated for relief of acute bronchospasm or for the treatment of asthma.
  • The following ISI is based on the Highlights section of the US Prescribing Information for Trelegy Ellipta.
  • Candida albicans infection of the mouth and pharynx has occurred in patients treated with fluticasone furoate, a component of Trelegy Ellipta.

GSK Submits Filing to FDA for Trelegy Ellipta Use in Patients With Asthma

Retrieved on: 
Wednesday, October 2, 2019
Research, Pharmaceutical, Medical devices, Science, Clinical trials, Biotechnology, Medical Supplies, FDA, Health, Drugs, Medicine, Combination drugs, Ellipta, Clinical medicine, Fluticasone furoate/vilanterol, Muscarinic antagonists, Fluticasone furoate, Umeclidinium bromide/vilanterol, Vilanterol, Chronic obstructive pulmonary disease, GlaxoSmithKline, asthma, the CAPTAIN Study, Trelegy Ellipta (FF/UMEC/VI) in the US, GSK, Innoviva

Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Key Points: 
  • Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
  • If approved, this filing would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the US.
  • Candida albicans infection of the mouth and pharynx has occurred in patients treated with fluticasone furoate, a component of Trelegy Ellipta.
  • Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA, ANORO ELLIPTA and TRELEGY ELLIPTA, which were jointly developed by Innoviva and GSK.

GSK Submits Filing to FDA for Trelegy Ellipta Use in Patients With Asthma

Retrieved on: 
Wednesday, October 2, 2019
FDA, Health, Clinical trials, General Health, Pharmaceutical, Drugs, Medicine, Combination drugs, Clinical medicine, Ellipta, Chronic lower respiratory diseases, Long-acting beta-adrenoceptor agonist, Fluticasone furoate/vilanterol, Muscarinic antagonists, Umeclidinium bromide/vilanterol, Respiratory therapy, Chronic obstructive pulmonary disease, asthma, the CAPTAIN Study, Trelegy Ellipta (FF/UMEC/VI) in the US, GSK, Innoviva

Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Key Points: 
  • Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
  • Christopher Corsico, SVP Development, GSK said: Around 30% of asthma patients adherent to ICS/LABA combination therapy still experience symptoms.
  • If approved, this filing would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the US.
  • Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA, ANORO ELLIPTA and TRELEGY ELLIPTA, which were jointly developed by Innoviva and GSK.