FDA Gives Tanezumab Fast Track Status for Chronic LBP

The FDA has granted fast track designation to tanezumab (Pfizer and Lilly) for treatment of osteoarthritis (OA) and chronic low back pain (CLBP).

Tanezumab, an investigational humanized monoclonal antibody that selectively inhibits nerve growth factor (NGF), is currently in the Phase III global clinical development program, which includes six studies of nearly 7,000 patients with OA, CLBP or cancer pain. The patients were selected based in part on not responding to currently approved therapies.