Phase III Studies on NGF Blocker Tanezumab for OA Pain to Resume


Pfizer and Lilly will resume development of the anti-nerve growth factor monoclonal antibody tanezumab for osteoarthritis pain, after the FDA lifted its ban imposed due to adverse effects in animal trials.

Phase 3 trials can continue for tanezumab, a monoclonal antibody against nerve growth factor that has shown promise against osteoarthritis (OA) pain, Pfizer Inc. and Eli Lilly and Company announced today.

A collaboration to develop the drug for OA and low back pain can resume now that the US Food and Drug Administration (FDA) has lifted a "partial clinical hold" on the program, prompted by concerns about adverse effects on the sympathetic nervous system of laboratory animals. Numerous clinical trials of the tanezumab were terminated due to the ban.

Research on tanezumab for cancer pain reportedly continued in the interim.

Lilly and Pfizer last month submitted additional nonclinical data that led FDA to reverse its decision regarding OA and low back pain. A Pfizer representative told Rheumatology Network that these studies show that tanezumab "does not cause neuron cell loss or death in the sympathetic nervous system." It does cause some neurons to shrink, but the effect "does not progress with chronic treatment, is reversible with treatment cessation, and is not believed to have functional consequence or significance. "

Research on tanezumab for cancer pain reportedly continued in the interim.

Within the past two years, published randomized trials sponsored by Pfizer have shoen tanezumab to have efficacy superior to both oxycodone and naproxen in randomized trials involving patients with hip or knee OA.

In a systematic review of nerve growth blockers including tanezumab for hip and knee OA, published in Osteoarthritis & Cartilage in January 2015, lead author Thomas Schnitzer MD of Northwestern University-Feinberg University School of Medicine in Chicago wrote: "antibodies to NGF provide efficacy in OA and ... general safety at the lower doses appears similar to placebo."

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