Roche and Trimeris seek full FDA approval for Fuzeon
BY Advocate.com Editors
December 17 2003 1:00 AM ET
Roche and Trimeris announced Tuesday that they had submitted data from two long-term studies of their HIV fusion inhibitor Fuzeon for full Food and Drug Administration approval. Fuzeon was granted accelerated approval by the FDA nine months ago. Accelerated approval is a special regulatory status granted by the FDA for a drug used to treat patients with serious or life-threatening illnesses and that provides meaningful therapeutic benefit to patients over existing treatments. Traditional approval is based on long-term studies showing a medication is safe and maintains a durable response.
"The 48-week data show that regimens with Fuzeon can substantially improve virological and immunological responses after almost a year of therapy," said Joel Gallant, associate professor of medicine and epidemiology at Johns Hopkins University in Baltimore. "The best responses have been seen among treatment-experienced patients with less advanced disease, but even patients with few or no other treatment options may derive some benefit from fusion inhibitor-based therapy over the longer term." The 48-week trial data show that more than twice the percentage of HIV patients on a Fuzeon-containing regimen had undetectable levels of HIV in their blood compared with patients on a standard antiretroviral cocktail. On average, patients receiving a Fuzeon-based regimen also experienced an increase of twice as many T cells from baseline as those achieved by patients on a regimen without Fuzeon.
A decision by the FDA on full approval is expected early next year.