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Incyte drops HIV drug

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Incyte is discontinuing development of its HIV candidate dexelvucitabine (DFC, formerly Reverset) due to "a recently observed increase in the frequency of grade 4 hyperlipasemia" in the firm's long-term extension of a Phase IIb trial, the firm says April 3. "Based on these observations, Incyte believes it is in the best interests of patients to discontinue development of DFC and has decided to stop enrollment of [a] recently initiated Phase IIb trial," the firm says. Incyte previously had cited hyperlipasemia, or pancreatic inflammation, as one of FDA's reasons for not giving a green light for the firm's Phase III program (1Pharmaceutical Approvals Monthly October 2005, p. 6). Incyte notes that "even though lower doses [of DFC] could be safer, those we've studied have not been effective," further reinforcing the decision to discontinue the nucleoside analog reverse transcriptase inhibitor...

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