HIV - Intelence (Etravirine) Receives Positive Opinion From European Committee For Human Medicinal Products

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Jun 2008 - 1:00 PDT

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Tibotec Pharmaceuticals, Ltd. announced today 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 approximately 10 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.

About etravirine

Etravirine was developed by Tibotec Pharmaceuticals Ltd. and will be marketed by Tibotec, a division of Janssen-Cilag in the European Union. Janssen-Cilag International NV will hold the marketing authorisation.

About Tibotec Pharmaceuticals Ltd.

Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need. www.tibotec.com

Ref: The Lancet, July 7th 2007