Novel Pfizer/Lilly pain med on shaky ground ahead of FDA adcomm meeting

March 22, 2021

Once touted as a promising opioid replacement for patients with osteoarthritis, a first-in-class pain medication is facing a slew of safety warnings as its FDA advisory committee meeting nears.

Developed by Pfizer and Eli Lilly, tanezumab is a monoclonal antibody designed to block nerve growth factor, a key protein involved in pain modulation for several conditions. The drug has been in development for over a decade and studied in over 40 trials — some of which have linked it to rapidly progressive osteoarthritis (RPOA). To address those issues, the companies modified trials for a lower dose and are now looking to get the drug approved under the FDA’s Risk Evaluation Mitigation Strategy (REMS). Yet, the FDA appears unconvinced that tanezumab is safe enough for use.  

This week, the FDA’s Arthritis Advisory Committee is set to meet alongside the Drug Safety and Risk Management Advisory Committee to answer one central question: “Will the REMS proposed by the Applicant ensure that the benefits of tanezumab outweigh the risks?”

Ahead of the meeting, the FDA released its own review of tanezumab explaining the agency’s concerns about the risk of RPOA, which were shown to persist even after patients stopped using the drug.

Although tanezumab has posted positive results from clinical trials, the agency called its efficacy “modest,” and pointed out that the drug has also been shown to increase the need for total joint replacements by 15 percent.

The advisory committees are scheduled to discuss the fate of tanezumab on Wednesday and Thursday. 

Read the FDA report.