The FDA granted its “traditional” approval to the HIV drug Fuzeon produced by Trimeris and Roche on Friday, the companies announced.
The FDA had approved Fuzeon for sale more than a year ago based on 24-week data in clinical trials. The accelerated approval is part of an FDA process to get to market drugs that fight life-threatening diseases.
The “traditional” approval is based on 48-week Phase III clinical trial data, which reported that 46 percent of patients receiving Fuzeon reported substantial improvements over the longer time period.
“The traditional approval of FUZEON further confirms its importance as a crucial option for treatment-experienced HIV patients,” said Steven Skolsky, CEO of Trimeris, in a statement. “The significance of this milestone is further reinforced by data recently presented at the XV International AIDS Conference, which show that Fuzeon is not only potent, but durable over 96 weeks.”