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, and will be marketed in Europe by Tibotec, a division of Janssen-Cilag. Janssen-Cilag International NV will hold the marketing authorisation.

INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.

The approval of INTELENCE demonstrates our ongoing commitment to providing innovative therapies for treatment-experienced HIV patients. We are committed to working with national health authorities to quickly make this drug available to people living with HIV in Europe who need new treatment options," said Mr Roger Pomerantz, President, Tibotec Research & Development.

This indication is based on week 24 analyses from two randomised, double-blind, placebo-controlled phase III trials in highly treatment-experienced patients with viral strains harbouring mutations of resistance to non-nucleoside reverse transcriptase inhibitors and protease inhibitors, where INTELENCE was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The data showed that significantly more patients in the INTELENCE arm achieved undetectable viral load (less than 50 copies/mL) compared to placebo (58.9 percent vs. 41.1 percent [p<0.0001]). INTELENCE was generally safe and well tolerated. Rash, generally mild to moderate, was the most common adverse event of moderate intensity or greater (> grade 2) associated with INTELENCE compared to placebo (9 percent vs. 3.2 percent).

The recommended oral dose of INTELENCE tablets is 200 mg (two 100mg tablets) twice daily following a meal. Patients may also disperse the tablets in a glass of water.  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.