CHMP Positive Opinion for Vocabria + Rekambys for Adolescents in EU

Key Details:

• Following potential approval, both Vocabria and Rekambys (in combination) will be indicated for the treatment of VS (HIV-1 RNA < 50 c/mL) HIV-infected adults and adolescents aged ≥12 years and weighing ≥35 kg, with no known mutations associated with NNRTI and INSTI resistance.
• Alongside the Vocabria injection, Vocabria tablets are also recommended for expanded use in VS adolescents (at least 12 years of age and weighing at least 35 kg), for short term treatment as either an oral lead-in or in cases of missed CAB+RPV injections.
• The positive opinion is supported by week 24 data from the MOCHA study showing no new safety concerns and 96.5% of adolescents remained VS
• Following the update, ViiV published a press release announcing the positive CHMP opinion for the combination, where Harmony P. Garges (CMO, ViiV) emphasized the benefits of the “first long-acting injectable regimen” for adolescents living with HIV, reaffirming the company’s commitment to expanding therapeutic options for young people and advancing inclusive HIV care.
• In its press release, ViiV stated that the marketing authorisation from the European Commission is “anticipated in the coming months”.

The expanded indication is expected to receive approval by February 2025, as the European Commission typically issues its decision approximately 60 days following a positive CHMP recommendation.