24th Mar 2020 10:00
(Correcting Paul Meunier's job title.)
(Alliance News) - GlaxoSmithKline PLC said its filing for the use of Trelegy Ellipta in adult patients with asthma has been accepted by the European Medicines Agency.
The pharmaceutical company said the regulatory body has accepted its submission seeking an additional indication for the use of Trelegy Ellipta - which is a once-daily, single inhaler triple therapy - as a treatment for asthma in adults.
Glaxo said its Phase three clinical study demonstrated a statistically "significant" improvement in lung function compared with Relvar/Breo Ellipta.
"The study showed that triple therapy in a single inhaler provides a potential new treatment option for asthma management in patients uncontrolled on ICS/LABA," said Paul Meunier, vice president of Respiratory Medicine at Innoviva.
Trelegy Ellipta was approved in the European Union in November 2017 for the treatment of patients with chronic obstructive pulmonary disease who are not adequately treated by an ICS/LABA combination, or a combination of LABA and long-acting muscarinic antagonist, Glaxo said. It added that if its submission is approved by the European Medicines Agency, it will be the first once-daily single inhaler triple therapy available for asthma and COPD.
The company said that 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 also accepted for filing in the US by the Food & Drug Administration in December 2019, and in Japan by the Ministry of Health, Labour & Welfare in November.
By Ife Taiwo; [email protected]
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