GSK and Innoviva file Trelegy Ellipta for Japan approval
GlaxoSmithKline, along with its partner Innoviva, has submitted a regulatory application to the Japanese Ministry of Health, Labour and Welfare for once-daily fluticasone furoate/umeclidinium/vilanterol under the proposed brand name ‘Trelegy Ellipta’, it announced on Tuesday, for the treatment of adults with chronic obstructive pulmonary disease.
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The FTSE 100 drugmaker said it was the first regulatory filing to be made in Japan for a triple COPD therapy in a single inhaler.
It said the new drug application was primarily based on data from the Phase III IMPACT study, which included 378 patients from Japan.
In the overall study population, FF/UMEC/VI was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist, Relvar/Breo Ellipta (FF/VI), and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), Anoro Ellipta (UMEC/VI), on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.
Similar trends were observed in the Japanese population for the primary endpoint as well as across multiple secondary and supportive efficacy endpoints.
, Head, Respiratory Therapy Area R&D, GSK said:
“COPD is a debilitating lung disease affecting over five million people in Japan,” said GSK’s head of research and development for the respiratory therapy area, Dave Allen.
“Many patients require combination treatment with different types of medicines to reduce both symptoms and exacerbations but there is currently no triple therapy available in Japan delivered in a single inhaler.
“If approved, once-daily FF/UMEC/VI delivered in the Ellipta would be an important innovation in the management of COPD in Japan alongside our current range of treatments.”
Dr Ted Witek, senior vice president and chief scientific officer at Innoviva, added that his firm was “delighted” to have filed a new drug application for the first single inhaler triple therapy for the treatment of COPD in Japan, where the prevalence of COPD was of public concern.
“We look forward to a decision from the MHLW, which, if positive, would provide a new therapeutic option for appropriate patients with COPD in Japan."
The two companies said the proposed indication was for the relief of various symptoms with COPD.
FF/UMEC/VI is currently licensed for use in the US, EU and a number of other countries under the brand name Trelegy Ellipta.
It contains three molecules, an ICS, a LAMA and a LABA, delivered in the Ellipta dry powder inhaler which is used across GSK's new portfolio of inhaled COPD medicines.