The U.S. Food and Drug Administration (FDA) Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted against Pfizer Inc. and Eli Lilly and Company’s potential osteoarthritis drug tanezumab.
Tanezumab is an investigational monoclonal antibody in a class of medicines known as nerve growth factor inhibitors. It is given by injection under the skin every two months. Pfizer and Lilly are positioning tanezumab as an alternative to nonsteroidal anti-inflammatory drugs or opioids. The advisory committee meeting was held to discuss tanezumab’s Biologics License Application that is currently under review by the FDA.
At the close of the two-day meeting, was a single voting question for the committee: “whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks.” Nineteen committee members voted against tanezumab and only one member voted for it.
OTW reached out to Pfizer and Lilly for a comment. “While we are disappointed in today’s outcome, we continue to believe that the clinical data presented for tanezumab supports its benefit-risk profile,” said Jim Rusnak, Chief Development Officer, Internal Medicine, Pfizer. “The patients whom we aim to help with tanezumab are suffering from significant, debilitating osteoarthritis pain and have exhausted available medical therapies and are hopeful for new, non-opioid treatments. We will continue to work with the FDA to determine next steps.”
OTW spoke with Flexion Therapeutics Inc. President and CEO Michael Clayman, M.D., to hear his perspective on the vote. Flexion is the manufacturer of ZILRETTA, which is an extended-release intra-articular therapy approved by the FDA for osteoarthritis-related knee pain. Clayman told OTW, “The world needs more effective therapies to treat osteoarthritis, unfortunately it doesn’t look like tanezumab will be one, but that remains to be determined by the FDA.”
Clayman explained, “When you investigate a new systemically administered drug, you can’t know with certainty what potential side effects you might encounter. You never initiate a clinical development program expecting to encounter serious adverse events. If you did, you probably wouldn’t go there in the first place. But having spent 20 years at Lilly and seeing many very promising drugs fall by the wayside for reasons of untoward safety, that experience influenced our strategic decision to focus on developing local therapies for musculoskeletal disease. We believe we can make a real difference for patients while largely avoiding systemic side effects and safety issues. ZILRETTA is a great example of that. It’s a product that delivers substantial and durable pain relief following a single injection with vanishingly low systemic exposures, and a pristine safety profile that is comparable to saline. It underscores why we took this approach in the first place.”
