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Roche and Trimeris seek full FDA approval for Fuzeon

Roche and Trimeris seek full FDA approval for Fuzeon

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.

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