Pfizer forced to discontinue more trials for novel pain drug tanezumab
This article was originally published in Scrip
Executive Summary
Pfizer is facing further disappointment with its promising first-in-class nerve growth factor (NGF) inhibitor, tanezumab. It has been forced by the US FDA to suspend clinical trials of the agent in chronic low back pain and painful diabetic peripheral neuropathy, following the recent suspension of the lead osteoarthritis programme due to safety concerns.
You may also be interested in...
Pfizer/Lilly Had Big Ambitions For Tanezumab; Are They Finally Dashed?
Given serious safety questions with tanezumab, the US filing seemed like throwing a Hail Mary; two FDA advisory panels overwhelmingly rejected the proposed risk management plan.
Tanezumab Dances Through Back Pain Studies With “Acceptable” Safety Answers
In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10 mg, but its 5 mg dose missed the statistically significant mark. Vitally, analysts are encouraged by safety data.
Pfizer/Lilly's Tanezumab Reduces Osteoarthritis Pain, But Is It Safe?
Pfizer and Lilly said tanezumab reduced pain in a Phase III osteoarthritis study, but safety is the biggest question for NGF inhibitors. Yet, while Regeneron and Teva discontinued dosing for their fasinumab at its highest dose, tanezumab was effective at both doses in its first Phase III test.