HIV Digest	HIV Digest Archive

The Swiss pharmaceutical company Roche said that tight supplies of its HIV drug candidate Fuzeon, known as T-20, mean only a limited number of patients will have access to it at first. Roche said the success in clinical trials of the drug, which awaits approval in the United States and European Union, together with increased resistance among patients to other HIV drugs, "will lead to a potentially faster and greater demand for Fuzeon than initially foreseen, with the potential for patient requirement for Fuzeon outstripping supply during its launch in 2003."

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Roche, which expects to have Fuzeon commercially available in the first quarter of 2003, said it is on track with its manufacturing schedule and has already taken steps to boost production capacity for the drug.

Roche said it is instituting an early access program for the drug - part of an effort by the Food and Drug Administration to make investigational drugs for serious illnesses available during late-stage clinical trials. Roche and partner Trimeris said they are in discussions with regulatory authorities, HIV-treatment physicians and HIV community advocates to establish fair criteria for early access and the allocation of Fuzeon during its launch.

Editor's Note: from the Wall Street Journal