GSK and Innoviva have announced that the EMA accepted a regulatory submission to expand the use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI to add the treatment of asthma in adults as an indication. Trelegy Ellipta has been approved in Europe for the treatment of COPD since November 2017. A previous Type II variation application was approved in November 2018, expanding the use of the inhaler for COPD to additional patients.
GSK also submitted an sNDA to the FDA in October 2019 to expand the use of Trelegy Ellipta to add the treatment of asthma. According to the announcement, both the FDA and Japan’s MHLW accepted supplemental applications for that indication in December 2019.
The new applications are supported by data from the Phase 3 CAPTAIN study of Trelegy Ellipta for the treatment of asthma, which met its primary endpoint of statistically significant improvement in lung function compared to Relvar/Breo Ellipta.
Read the GSK and Innoviva press release.
