Triangle Pharmaceuticals hopes to win US marketing approval for its once daily nucleoside analogue FTC (emtricitabine, Coviracil) by the third quarter of 2003, Triangle Chief Executive Daniel G. Welch said in a press statement issued by the company on Monday. The statement followed acceptance by the Food and Drug Administration of Triangle’s New Drug Application. A European license application will follow before the end of 2002.
Coviracil is potentially distinctive only because treatment failure is associated with a lower frequency of M184V resistance mutations compared to 3TC, making the use of abacavir in a subsequent regimen a more solid option when thymidine analogue mutations are present (high level abacavir resistance is associated with M184V and three or more TAMs).
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