EMA accepts GSK filing for Trelegy Ellipta use in adults with asthma

GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) has announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency (EMA).

The submission is supported by the pivotal Phase III clinical study (CAPTAIN), conducted in 2,436 adult asthma patients across 15 countries whose disease remained inadequately controlled despite treatment with a combination of an inhaled corticosteroid and a long-acting β2-agonist (ICS/LABA). The study met its primary endpoint, demonstrating a statistically significant improvement in lung function compared with the ICS/LABA, Relvar/Breo Ellipta.

There is currently no single inhaled triple therapy available for the treatment of asthma in Europe. Asthma, a chronic lung disease that inflames and narrows the airways, affects 358 million people worldwide. Even when adherent to ICS/LABA treatment, at least 30% of asthma patients continue to experience symptoms, indicating that they require further treatment.

Trelegy Ellipta was approved in the European Union in November 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) who are not adequately treated by an ICS/LABA combination, or a combination of LABA and long-acting muscarinic antagonist (LAMA). If approved this would be the once-daily single inhaler triple therapy available for asthma and COPD.

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Regulatory applications have also been submitted for the Trelegy duplicate licences, Elebrato Ellipta and Temybric Ellipta. Submissions for the use of Trelegy Ellipta for the treatment of adult asthma patients were accepted for filing in the US by the FDA in December 2019 and in Japan by the Ministry of Health, Labour and Welfare in November 2019, and these regulatory review processes are ongoing.

Medical Dialogues has previously reported drug firm GlaxoSmithKline Pharmaceuticals recently reported a consolidated net loss of Rs 661.16 crore for the December 2019 quarter, mainly on account of financial impact related to the voluntary recall of Zinetac.

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