Tibotec's darunavir approved in USA

Belgium-based Tibotec, a Johnson & Johnson company, has welcomed the US approval of TMC114 (darunavir), its new boosted protease inhibitor, which it says provides a potent novel treatment combination with Swiss drug major Roche's fusion inhibitor Fuzeon (enfuvirtide) that can successfully combat treatment-resistant HIV.

According to Tibotec, data have shown that up to two-thirds of patients with extensive prior exposure to anti-HIV drugs achieved undetectable levels of virus (less than 50 copies of viral RNA per ml of blood) when darunavir was used with Fuzeon, a dramatic result that has never been seen before in this patient population.

For the first time, in late-2005, the US Department of Health and Human Services guidelines established that maximal suppression of HIV was the goal for treatment-experienced patients and recommended Fuzeon with an active boosted PI, such as darunavir, as a strategy to achieve it.