FDA Advisory Committee Votes Against Tanezumab for Osteoarthritis Pain

A joint advisory committee for the U.S. Food and Drug Administration (FDA), comprising the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 19-1 against the proposed risk evaluation and mitigation strategy (REMS) for tanezumab. The drug is under consideration for treating moderate-to-severe osteoarthritis (OA) pain in adult patients for whom other analgesics are ineffective or inappropriate.

Tanezumab is an investigational monoclonal antibody that targets nerve growth factor (NGF), a mechanism distinct from current OA pain treatments like opioids and NSAIDs. In clinical studies, the drug has not demonstrated a risk of addiction, misuse, or dependence. Pfizer and Eli Lilly, the companies developing the drug, expressed disappointment but affirmed their belief in the drug's benefit-risk profile for patients with limited options.

"While we are disappointed with today's outcome, we continue to believe that tanezumab has a positive benefit-risk profile for patients with moderate-to-severe osteoarthritis pain for whom current treatments are ineffective or not appropriate," said Ken Verburg, tanezumab development team leader at Pfizer Global Product Development. "We will continue to work with the FDA as the agency continues its review of our application."

The advisory committee's recommendation is not binding for the FDA, but it carries significant weight in the regulatory review process. The application relies on data from 20 clinical studies including over 4,500 patients with OA. Osteoarthritis is the most common form of arthritis and a leading cause of chronic pain, impacting millions worldwide.