Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Reuters NewMedia - Monday, November 18, 2002
The company added that large-scale manufacturing of the drug, formerly known as T20, is under way to try to meet high demand for the product when it is approved, probably in the first quarter of next year.
Patient groups and AIDS activists have been clamouring for access to the injectable drug which offers hope when people become resistant to existing antiretroviral therapies.
Fuzeon, co-developed with Trimeris Inc TRMS.O , is the first of a new class of antiretroviral drugs called "fusion inhibitors". Unlike existing anti-HIV drugs that work inside the cell, it is designed to block HIV from entering healthy human immune cells.
The drug is difficult to make and earlier this year Roche said it would have to ration supplies initially.
New data presented by Roche at the Sixth International Congress on Drug Therapy in HIV Infection in Glasgow showed that patients secured even greater benefit from combination therapy with Fuzeon when at least two other drugs within their cocktail therapy were still active against the HIV virus.
"The combination of better than expected efficacy, tolerability and adherence data with the increasing incidence of drug resistance means demand for Fuzeon will be greater than initially anticipated," said Dr David Reddy, Roche's head of HIV/AIDS.
He said the first large-scale manufacturing campaign was in progress to support the launch of Fuzeon.
"We will be updating our supply estimates based upon the information from the full campaign. This will then enable us to refine our plans for managing the launch to ensure continuous drug supply for all patients beginning Fuzeon therapy," he said.
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