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www.fdanews.com/articles/102439-kiadis-meets-with-fda-on-reviroc

Kiadis Meets With FDA on Reviroc

December 19, 2007

The FDA has found that data from Dutch drugmaker Kiadis Pharma’s Phase II Reviroc trial is sufficient to support the start of a Phase III study.

In the Phase II trial, treatment with Reviroc demonstrated improved overall survival after autologous bone marrow transplantation in non-Hodgkin’s lymphoma patients. The Phase III trial will focus on patients with large B cell lymphoma, Kiadis said. 

The company expects to file investigational new drug and orphan drug designation applications shortly.