Johnson and Johnson reports positive CHMP opinion for Intelence

Tibotec Pharmaceuticals, a Johnson & Johnson company, has announced that Intelence has received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for Intelence (etravirine) as a treatment for HIV.

The proposed indication for the drug requires its use in conjunction with other antiretroviral medicinal products and a boosted protease inhibitor.

It will be used to treat HIV-1 infection in adult patients who are antiretroviral treatment-experiences.

Etravone, also known as TMC125, is a the first next-generation non-nucleoside reverse transcriptase inhibitor to be introduced in nearly a decade.

The positive opinion from the CHMP is based on analyses at week 24 of the two phase III Duet studies.

Roger Pomerantz, president of research and development at Tibotec, said: “We are encouraged by the positive opinion from the CHMP regarding etravirine.”

He added the company would continue to work together with regulatory authorities to make the drug available to treatment-experienced patients in Europe who need new therapy options that are well tolerated.

In February 2008, Johnson & Johnson announced the publication of positive 48-week efficacy and safety data for Intelence as part of HIV combination therapy.