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FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy

the use of INTELENCE.

-- The use of other active antiretroviral agents with INTELENCE is

associated with an increased likelihood of treatment response.

-- In patients who have experienced virologic failure on a

NNRTI-containing regimen, do not use INTELENCE in combination with

only N[t]RTIs.

-- The risks and benefits of INTELENCE have not been established in

pediatric patients or in treatment-nave adult patients.

FDA accelerated approval procedures allow for earlier approval of drugs that provide a meaningful therapeutic benefit over existing treatment for serious or life-threatening diseases. The INTELENCE approval is based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the DUET-1 and -2 studies. Longer-term data will be required before the FDA can consider traditional approval for INTELENCE.

"It is very inspiring to our R&D organization to see an additional compound so quickly emerge from our pipeline and reach patients who need it," said Roger Pomerantz, M.D., FACP, President, Tibotec Research and Development. "With one of the most robust virology research and development programs in the industry, we are dedicated to continuing to deliver innovative approaches in HIV management in the years to come."

"The addition of INTELENCE following the launch of our first antiretroviral just two years ago is a significant milestone for Tibotec Therapeutics," said Glenn Mattes, President, Tibotec Therapeutics. "In partnership with Tibotec R&D, we are committed to continuing to bring new options to people living with HIV."

The NNRTI Class

INTELENCE is the first new NNRTI to be introduced in nearly 10 years. It is also the first NNRTI to show antiviral activity in patients with NNRTI-resistant virus. NNRTIs block reverse transcriptase, a key enzyme the HIV virus uses to replicate. NNRTI drug resistance occurs when HIV develops mutations that par

SOURCE Tibotec Therapeutics
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