Roche and Trimeris' HIV drug Fuzeon cleared on schedule by US FDA

The US Food and Drug Administration has approved the first fusion inhibitor treatment for HIV, in the form of Roche and Trimeris' Fuzeon (enfuvirtide), after a six-month accelerated review. The drug represents the first new class of HIV treatment to be registered for marketing since the approval of the HIV protease inhibitors, spearheaded by Roche's own Invirase (saquinavir), in 1995.

Specifically, Fuzeon has been approved for the treatment of HIV-1 infection, in combination with other antretrovirals, in treatment-experienced patients with evidence of HIV-1 replication despite ongoing therapy. Approval was based on the results of the TORO 1 and TORO 2 trials, which showed that adding Fuzeon to an optimized background regimen of anti-HIV drugs led to greater immunologic improvements compared to patients receiving an individualized regimen alone, with Fuzeon-treated individuals twice as likely to achieve undetectable plasma levels of HIV (Marketletters passim).

Bill Burns, head of Roche Pharmaceuticals, commented that "Fuzeon represents a major advance in the fight of HIV/AIDS. As more and more people with HIV are running out of options due to HIV drug resistance, new options are urgently required."