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Home Industry News Gilead Sciences’ new HIV therapy accepted for EU review

Gilead Sciences’ new HIV therapy accepted for EU review

24th August 2015

Gilead Sciences' new combination therapy for HIV has been accepted for review by the European Medicines Agency (EMA).

The investigational, once-daily regimen combines emtricitabine, tenofovir alafenamide and rilpivirine (R/F/TAF) in a single tablet. It was developed in collaboration with Janssen, the creator of rilpivirine

With the acceptance of the company's marketing authorisation application, the treatment is now under evaluation by the EMA, and could lead to final European Commission approval being granted for the treatment.

The application is supported by a body of clinical data that demonstrates the safety and efficacy of the therapy.

Dr Norbert Bischofberger, executive vice-president of research and development and chief scientific officer at Gilead Sciences, said: "With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favourable safety profiles."

This comes after the firm's investigational fixed-dose F/TAF combination therapy for HIV was also accepted for EU review earlier this year.ADNFCR-8000103-ID-801798451-ADNFCR

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