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    Home > Active Ingredient News > Immunology News > Heavy! Trelegy Ellipta has been approved for a new allergy: the first single inhaler triple therapy for asthma and slow lung resistance!

    Heavy! Trelegy Ellipta has been approved for a new allergy: the first single inhaler triple therapy for asthma and slow lung resistance!

    • Last Update: 2020-09-26
    • Source: Internet
    • Author: User
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    !--, 2020 // -- GlaxoSmithKline (GSK) and partner Innoviva recently jointly announced that the U.S. Food and Drug Administration (FDA) has approved its triple inhalation agent Trelegy Ellipta (Chinese : Full Rele, Generic Name: Fluticasone Furoate/Umeclidinium/Vilanterol, FF/UMEC/VI, 100/62.5/25 micrograms) A new adaptive disorder for the treatment of asthma in adults (up to 18 years of age).
    , the drug was approved for the treatment of patients with chronic obstructive pulmonary disease (COPD).
    Trelegy Ellipta is not suitable for the relief of acute bronchitis.
    the treatment of asthma, there are 2 FDA approved doses (FF/UMEC/VI, 100/62.5/25 micrograms, 200/62.5/25 micrograms);
    Trelegy Ellipta is a single inhaler triple (ICS/LAMA/LABA) therapy that is given once a day through the Ellipta ® dry powder inhaler, which covers the three most widely used inhalation drugs in clinical treatment today and consists of an inhalable corticosteroid Steroid (ICS) fluticasone furoate (FF), a long-acting toxaline antagonist (LAMA) umeclidinium (UMEC) and a long-acting beta-2-subject exciter (LAB) Vilanterol (VI).
    this approval means that Trelegy is the first single inhaler triple therapy approved for asthma and COPD maintenance therapy, and the only convenient daily inhaler triple therapy in the United States.
    's announcement marks GSK's sixth major pharmaceutical approval in 2020, covering highly unseolfic therapeutic areas such as cancer, HIV, respiratory and chronic kidney disease.
    Trelegy's approval for maintenance therapy for 18-year-olds and older has introduced a new model for managing about 30 percent of adult asthma patients who still have asthma symptoms despite their insistence on inhaling a corticosteroid/long-acting beta-excited agent (ICS/LABA) joint treatment.
    data from the Phase III CAPTAIN study show that Trelegy Ellipta's treatment resulted in a statistically significant improvement in lung function in adult patients with asthma who received ICS/LABA combined treatment but their condition was still under control compared to ICS/LABA, Relvar/Breo Ellipta (FF/VI).
    , GSK's chief scientific officer and president of research and development, said: "Millions of asthma sufferers in the United States rely on multiple inhalers to help control their condition and symptoms.
    today's approval is an important step forward for these patients because it allows them to benefit from triple therapy by using a single inhaler once a day.
    Asthma Inhaler (Photo: urgentcarefl.com) Asthma is a chronic lung disease that can inflamm and narrow the respiratory tract, affecting 358 million people worldwide.
    even if ICS/LABA is adhered to, at least 30% of asthma sufferers still have symptoms that require further treatment.
    In addition, additional bronchial dilators delivered through multiple inhalers have been shown to have beneficial effects on asthma symptoms and lung function, and a single inhaler triple therapy will bring a new treatment model to adults who are still suffering from symptoms in the ICS/LABA combination.
    approval of Trelegy Ellipta for asthma treatment is based on a new supplemental drug application (sNDA), which includes the results of the key Phase III clinical study CAPTAIN (NCT02924688).
    the study was conducted in 2,436 adult asthma patients in 15 countries worldwide who received ICS/LABA (250mcg/day fluororopylate or equivalent) maintenance medication but had inadequate control of the condition, and assessed the daily FF/UMEC/VI (100/31.25/25, 100/62.5/25, 200/31.25/25, 200/62.5/25 mcg) relative to the daily FF/VI (100/25 and 200/25 mcg) efficacy and safety.
    results show that the study reached the main endpoint: (1) compared to Relvar/Breo (FF/VI) 100/25mcg, FF/UMEC/VI 100/62.2 5/25mcg significantly improved lung function (measured by changes in FEV1 valley relative to baseline at week 24) and the data were statistically significant (p.001,9 5%CI: 66-153 ml) ;(2) compared to Relvar/Breo (FF/VI) 200/25mcg, FF/UMEC/VI 200 /62.5/25mcg significantly improved lung function by 92 ml and the data were statistically significant (p.001,95% CI: 49-135 ml).
    the United States and the European Union, Trelegy Ellipta was approved in September and November 2017 for the treatment of COPD patients, respectively.
    it is worth mentioning that the drug is the first single inhaler triple therapy approved for use in the group of COPD patients treated with dual-acting bronchid dilators (ICS/LABA or LABA/LAMA) but with poor condition control, and is suitable for: as a Long-term, daily maintenance therapy to treat airflow obstruction in COPD patients (including chronic bronchitis and/or emphysema), including patients who have received poor control of FF/VI and those who have been treated in combination with a fixed dose of FF/VI.
    the drug is also suitable for patients with a history of COPD exacerbation, reducing COPD exacerbation.
    !--/ewebeditor:page--!--ewebeditor:page-title" -- in China, Trelegy Ellipta was officially approved for treatment with COPD stabilization in November 2019.
    At the end of March this year, GSK announced that Trelegy Ellipta, the world's first one-day triple inhalation preparation for stable COPD treatment, will be launched on Ali Health Platform, and that GSK will further expand the accessability of "Full Rele" in the Chinese market to meet the needs of the majority of patients with coping with coping.
    original source: FDA approvals Trelegy Ellipta as the First Once-Daily Single Inhaler Triple Therapy for The Treatment of Both Asthma and COPD in the US !--/ewebeditor:page--
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