Roche Warns That ‘Tight Supplies’ of Fusion Inhibitor Fuzeon Will Limit Availability
Drug maker Roche Holding AG on Friday announced that it will only be able to offer its new injectable HIV treatment Fuzeon to a "limited number" of patients because of "tight supplies" of the medication, Dow Jones International News reports. "In the short term, we do not have the flexibility to increase production beyond our current capacity to meet a potentially higher than anticipated demand," William Burns, head of Roche Pharmaceuticals, said (Dow Jones International News, 8/2). The drug, formerly known as T-20, is the first in a class of treatments called fusion inhibitors that prevent HIV from entering a person's cells. All of the currently approved HIV treatments attack the virus after it has already infected a cell. In clinical trials, Fuzeon "slashed the amount of [HIV] in the blood" of patients who had developed resistance to other treatments. Only 3% of participants stopped the treatment because of injection site reactions (Hirschler, Reuters/Philadelphia Inquirer, 8/3). Roche is seeking fast-track FDA approval for Fuzeon and plans to initially market it through an early access program. Combined with continuing clinical trials, the access program, which is expected to begin in September or October, will make the drug available to more than 3,000 patients by next March. Roche expects to increase production of Fuzeon to supply the drug to about 25,000 patients by the end of 2003, David Reddy, head of the company's HIV department, said (Dow Jones International News, 8/2).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.