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Published on 4 September 2008

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EMEA authorisation for etravirine

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The European Medicines Agency (EMEA) has granted marketing authorisation for the anti-HIV medication Intelence (etravirine).

Intelence is a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) and the first to show efficacy in patients with NNRTI-resistant HIV. Intelence is the first new NNRTI to be introduced in approximately 10 years. Also known as TMC125, Intelence was developed by Tibotec Pharmaceuticals Ltd, and will be marketed in Europe by Tibotec, a division of Janssen-Cilag. Janssen-Cilag International NV will hold the marketing authorisation.

“NNRTIs have been trusted by physicians and used in antiretroviral therapy for more than a decade, but NNRTI resistance has limited the use of this important class of HIV medication,” said Professor Christine Katlama, Head of the AIDS Clinical Research Unit in the Department of Infectious Diseases at Pitié-Salpêtrière Hospital in Paris, France.

“Intelence extends the NNRTI class to thousands of treatment-experienced patients in Europe who have NNRTI-resistant virus, providing them with the potential to suppress their virus to undetectable levels – the ultimate treatment goal.”

The EMEA decision follows similar approvals earlier in the year in Switzerland, Russia, Argentina, Canada, South Korea and the US. Commercial launches will vary from country to country, based on local price and reimbursement discussions with national authorities.

Janssen-Cilag



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