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news.The FDA has requested that Incyte Corporation conduct a further phase II trial to confirm the efficacy and safety of its HIV drug, Reverset.
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Shares in Incyte have been hit hard, tumbling over 40% in the wake of the news. The extra trial is likely to represent a delay in the drug’s path to market of 12 to 18 months.
“Based on the outcome of this meeting, we need to carefully review and discuss FDA’s input. We also need to determine how such a second phase II study could best be conducted,” stated Paul Friedman, president and CEO of Incyte. “If the results confirm those seen in Study 203, it is possible this second phase II study could be considered one of two registration trials.”
Reverset is a nucleoside reverse transcriptase inhibitor (NRTI) that is being developed as a therapy for treatment-experienced HIV patients.