Janssen receives CHMP backing for EU approval of HIV therapy Symtuza

Janssen has announced that its new HIV therapy Symtuza has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending marketing authorisation for the new once-daily darunavir-based single tablet regimen.

If approved, it will become the only darunavir-based single-tablet regimen indicated for the treatment of HIV-1 infections in adults and adolescents aged 12 years and older with a body weight of at least 40 kg, with genotypic testing guiding use.

Symtuza will be the only treatment that can deliver the adherence advantages of a single-tablet treatment coupled with the high genetic barrier to resistance that darunavir offers.

Dr Lawrence Blatt, global therapeutic area head for Janssen's infectious disease therapeutics division, said: "We are extremely excited to be one step closer to getting this therapy to people living with HIV and in doing so hope to reduce the treatment burden faced by many living with the virus."

A final decision from the European Commission is expected in the coming months.

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