Roche Fuzeon (T-20) NDA
Executive Summary
Roche and Trimeris file NDA for HIV fusion inhibitor Fuzeon (T-20/enfuvirtide) Sept. 17. The companies are establishing a 1,200-patient access program in anticipation of supply constraints (1"The Pink Sheet" Aug. 5, In Brief)...
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Roche Fuzeon (T-20) supply
Roche and Trimeris are setting up 1,200-patient access program for HIV fusion inhibitor Fuzeon (T-20/enfuvirtide) in anticipation of supply constraints at time of launch. The program will commence in September/October and reach its patient cap by March 2003, Roche said. "In the short-term, we do not have the flexibility to increase production beyond our current capacity to meet a potentially higher than initially anticipated demand," Roche said. The companies will file Fuzeon in the third quarter and will receive a "fast-track" review. One estimate for expanded availability would have the company supplying 40,000 patients by end of 2004..
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