| |
Incyte Announces Outcome of Discussions with FDA Regarding Reverset
|
| |
| |
WILMINGTON, Del.--(BUSINESS WIRE)--Sept. 28, 2005--Incyte Corporation (NASDAQ:INCY) announced today that it 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, which were presented in July at the IAS meeting, 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.
Paul A Friedman, president and CEO of Incyte, stated, "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. 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."
|
|
| |
| |
|
|
|
