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Tibotec Pharmaceuticals Ltd has announced that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending conditional approval of its HIV medication Intelence (etravirine) in the European Union.
Etravirine, also known as TMC125, is a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) and is the first new NNRTI to be introduced in about ten years. The conditional marketing authorisation from the European Commission is expected in the coming months.
The positive opinion from the CHMP, the committee responsible for the scientific assessment of new medicinal products, will be reviewed by the European Commission, which then has authority to approve medicines for use throughout the European Union.
The CHMP’s positive opinion is based on week 24 analyses from the DUET studies – two randomised, double-blind, placebo-controlled phase III trials, the results of which have been published in The Lancet.
Etravirine was developed by Tibotec Pharmaceuticals Ltd and will be marketed by Tibotec, a division of Janssen-Cilag in the European Union.