Europe: Virology – HIV - CHMP Meeting Minutes March 2022 – Competitor Update

Please find below some relevant information that report a summary of regulatory milestones for competitor products of interest to Gilead’s developing and marketed products in virology.

CHMP assessed procedures scope: Non-Clinical and Clinical aspects

• Tivicay (dolutegravir)
  • “Following the recommendation (REC) requested during the procedure EMA/H/C/2753/X/58G, the MAH submits the manuscript of the ODYSSEY study which contains efficacy and long-term safety results to 96 weeks for Tivicay tablets. This study is an open-label, multicentre, randomized (1:1), non-inferiority, Phase II/III, 96-week, 2-arm clinical trial to compare the efficacy and toxicity of dolutegravir (DTG) plus 2 NRTIs vs. standard of care in HIV infected children aged less than 18 years who are starting first-line ART (ODYSSEY A) or switching to second-line ART (ODYSSEY B).
  • Based on the results, no amendments to the product information for DTG (Tivicay) are considered warranted and therefore, no updated SmPC is provided as part of this application.”
  • Positive Opinion adopted by consensus on 17.03.2022.
• Trogarzo (ibalizumab) - Theratechnologies
  • Update of section 5.1 of the SmPC in order to add additional efficacy data based on results from study TMB-311, a multicentre, expanded access phase 3 study providing post-hoc long-term data on patients from study TMB-301.
  • Request for Supplementary Information adopted on 24.03.2022.