Pfizer and Eli Lilly once had high hopes for tanezumab — a novel pain medication that was seen as a potential game-changer in the opioid crisis. But unfortunately, the joint venture to develop the drug for painful conditions such as osteoarthritis has officially ended in defeat.
This week, Lilly announced in a Q3 earnings statement that the companies have discontinued the global development program for the drug. The drugmakers made the call after receiving negative feedback from regulators in the EU and a complete response letter from the FDA.
Tanezumab, a monoclonal antibody designed to block nerve growth factor (NGF), a key protein involved in pain modulation for several conditions, was in development for over a decade and studied in dozens of trials. Some of the trials showed that the drug could be effective, but it was also linked to rapidly progressive osteoarthritis. The companies adjusted the trials to study a lower dose — but then tanezumab was found to be less effective.
The bottom line was that the benefits of tanezumab didn’t seem to outweigh the risks, and the prospects for winning regulatory approval were slim.
The development of other NGF drugs — such as an experimental J&J drug, and Teva and Regeneron’s fasinumab — have struggled in clinical trials due to safety concerns. Although the development of fasinumab is ongoing and the companies have announced positive topline results from a phase 3 trial of the drug — the entire pipeline for anti-NGF antibodies has shrunk over the last decade as several therapies have been shelved.
