A meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) that had been scheduled for April 21, 2020 has been postponed due to the COVID-19 pandemic. No new meeting date was announced.
The committee was due to discuss a supplemental NDA for GSK’s Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, for a label change to claim reduction in all-cause mortality in COPD patients. According to the meeting agenda, “The focus of the discussion will be on the efficacy data submitted to support the proposed labeling claim, including the results from the Informing the Pathway of COPD Treatment (IMPACT) trial and the influence of inhaled corticosteroids (ICS) withdrawal on the results.”
Trelegy Ellipta was initially approved by the FDA in September 2017, and the first sNDA for the inhaler for an expanded indication based on data from the IMPACT study was submitted by GSK in November 2017, with approval of that sNDA coming in April 2018.
Read the FDA notice.
View the PADAC meeting agenda.
