FDA Lifts Clinical Hold, Tanezumab Trial to be Resumed
This decision was made after the Food and Drug Administration (FDA) agreed to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February 2015.
In the previous clinical studies, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medications. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
Tanezumab is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), by selectively binding to NGF. This inhibits the protein from activating pain-signaling neurons.