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British pharmaceutical giant GlaxoSmithKline (GSK) and partner Innoviva recently announced that the European Commission (EC) has approved an extension of the triple therapy Trelegy Ellipta (FF/UMEC/VI) label for chronic obstructive pulmonary disease (COPD) Treatment of patients, specifically: receiving a double bronchid dilate or an inhaled corticosteroid (ICS) and a long-acting beta-2 astration (LABA) in a combined treatment of moderate to severe COPD patients who did not adequately control the condition.
Trelegy Ellipta is the first single inhaler triple therapy approved for a group of COPD patients with poor control of the condition of double bronchid expanders. The drug is an ICS/LAMA/LABA combination therapy that is given once a day through GlaxoSmithKline's Elapta dry powder inhaler. Trelegy Ellipta covers the three most widely used inhalation drugs in COPD clinical treatments, consisting of FF (Fluticasone furoate, fluorotikasone, an inhaled corticosteroid, ICS) and UMEC (umeclidinium, a long-acting venom antagonist, LAMA) and VI (vilanterol, Virantero, a long-acting 2-acting beta-excited agent).
in the European Union, Trelegy Ellipta's new adaptation is a daily maintenance therapy for moderate to severe COPD patients who do not adequately control the condition with ICS/LABA combination therapy or LABA/LAMA combination therapy. In Europe, Trelegy Ellipta was originally approved in November 2017 for moderate to severe COPD patients with ICS/LABA combination therapy that does not adequately control the condition. In the United States, Trelegy Ellipta was approved in September 2017 as a long-term, daily maintenance therapy for the treatment of COPD patients, including those receiving poor FF/VI disease control and those who have been treated in combination with a fixed dose of FF/VI.
Hal Barron, President and Chief Scientific Officer of GSK Research and Development, said: 'We are pleased that the European Commission has approved trelegy Ellipta's expanded use as this will enable more COPD patients to benefit from this important drug.
although bronchid dilation is recognized as the basis for COPD treatment, many patients may continue to experience symptoms and worsening of the disease over time. Trelegy Ellipta's expanded adaptation reflects evidence supporting the drug's potential benefits in a broader group of patients than the original applicable group, and will provide these patients with a daily single inhaler triple therapy option for the first time.
. Paul Meunier, vice president of respiratory medicine at
Innoviva, said, 'We are pleased that the daily single inhaler triple therapy Trelegy Ellipta is now available to COPD patients whose condition is not adequately controlled by a double trachea expander, which will give them a new option to help manage their disease.'
this label update is based on data from landmark clinical study IMPACT, which showed that Trelegy Ellipta outperformed dual-acting bronchid dilates ICS/LABA Relvar/Breo Ellipta (FF/VI) and LAMA/LABA Anorolip Ellipta (UMEC/VI) at several clinically important endpoints, including reducing deterioration of the condition, improving lung function and health-related quality of life. (Bio Valley)