INCYTE REPORTS OUTCOME OF DISCUSSIONS WITH FDA
Incyte has met with representatives from the FDA yesterday regarding the development
of Reverset, Incyte's nucleoside reverse transcriptase inhibitor (NRTI) that
is being developed as a therapy for treatment-experienced HIV patients.
The purpose of the meeting was to discuss the results of a recently completed Phase II trial and the company's plans to move Reverset into two Phase III pivotal trials. At the meeting, the FDA did not approve of the company moving into Phase III studies. The agency requested that the company conduct another Phase II trial to provide additional data to support the efficacy and safety demonstrated in the original Phase II study with the drug.