GSK: Positive CHMP opinion for Vocabria against HIV

(CercleFinance.com) - GSK announces that ViiV Healthcare, its specialist HIV treatment company, has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) for the marketing authorization of Vocabria (long-acting cabotegravir injections) combined with Rekambys (long-acting rilpivirine injections) from Johnson & Johnson.


This treatment is intended for adolescents aged 12 and over, weighing at least 35 kg and virologically suppressed.

If approved, this would be the first long-acting injectable combination available for adolescents living with HIV.

The CHMP's positive opinion is based on the MOCHA study (Phase I/II), which showed that after 24 weeks, 96.5% of the 144 participants remained 'virologically suppressed', with a clear preference for injections over oral treatments.

Approval by the European Commission is expected 'shortly'.

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