GSK submits sNDA for Trelegy Ellipta for the treatment of asthma

GlaxoSmithKline and Innoviva announced that GSK has submitted a supplemental new drug application for the use of the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of asthma. The FDA initially approved Trelegy Ellipta for the treatment of COPD in September 2017 and approved an sNDA to expand the indication for wider use of the DPI for COPD in April 2018.

In May 2019, the companies announced that the Phase 3 CAPTAIN study of Trelegy Ellipta for the treatment of asthma had met its primary endpoint.

GSK Senior VP of Development Christopher Corsico commented, “Around 30% of asthma patients adherent to ICS/LABA combination therapy still experience symptoms. This filing is an important step towards giving asthma patients an additional treatment option. If approved, this filing would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the US.”

Read the GSK and Innoviva press release.