Cabotegravir/rilpivirine long-acting injectable HIV drugs submitted to EMA

Simon Collins, HIV i-Base

On 29 July 2019, ViiV Healthcare issued a press release announcing that the cabotegravir/rilpivirine long acting intramuscular injection has been submitted to the European Medicine Agency (EMA). It is likely that this will take 12 months. [1]

The submission is based on results from the phase 3 ATLAS and FLAIR studies. [2]

US submission to the FDA was three months earlier in April 2019, with a priority review expected by end of December 2019. [3]


  1. ViiV press release. ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly injectable treatment for HIV. (29 July 2019). (direct link)
  2. Collins S. Phase 3 results with dual therapy cabotegravir/rilpivirine long-acting injections: ATLAS and FLAIR studies. HTB: 20 (3). (12 March 2019).
  3. ViiV press statement. ViiV Healthcare submits New Drug Application to US FDA for the first monthly injectable two-drug regimen of cabotegravir and rilpivirine. (29 April 2019). (direct link)

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