FDA gives go ahead to restart Phase III trials of tanezumab in Chronic Pain-Pfizer/Eli Lilly

Pfizer and Eli Lilly are preparing to resume the Phase III clinical program for tanezumab as a treatment for Chronic Pain. This announcement follows a decision by the FDA 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 prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. 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. As a result, Pfizer expects to receive a $200 million upfront payment from Lilly in accordance with their collaboration agreement.

Comment: viewed as a possible blockbuster, tanezumab would need to be given for very long periods of times, due to the chronic nature of the problem it addresses. Tanezumab is the only anti-NGF antibody in advanced clinical trials , so it should enjoy a significant first-in-class advantage.