Posted by Michael Wonder on 29 Feb 2020
GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma
27 February 2020 - Submission supported by pivotal CAPTAIN study demonstrating statistically significant improvement in lung function compared with the ICS/LABA, Relvar/Breo Ellipta.
GlaxoSmithKline and Innoviva today 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.
