Pfizer's Tanezumab receives almost unanimous rejection by FDA Adcom

From Endpoint news this morning......Paradigm's biggest competitor in the OA space looks to have fallen over.


FDA adcomm lines up almost unanimously against Pfizer’s osteoarthritis drug tanezumab

Zachry BrennanSenior EditorEdward Cheng

Outside experts advising the FDA voted 19 to 1 against (one of the two consumer reps voted yes) Pfizer’s potential osteoarthritis drug tanezumab, saying the proposed risk evaluation and mitigation strategy (REMS) will not ensure the benefits of the drug outweigh the risks.

Two different FDA advisory committees on arthritis and drug safety came together over the last day and a half to review Pfizer’s drug, with panelists raising serious concerns about the safety of the drug and how effective it is.

Edward Cheng, professor of reconstructive surgery at the University of Minnesota, said tanezumab “does not fill” the unmet need for an effective drug for osteoarthritis and chronic arthritis pain, explaining that it’s no better than aspirin or ibuprofen, or even placebo.

Other panelists raised concerns about Pfizer’s proposed REMS, echoing what the FDA said in its briefing documents about how a REMS might not prevent or halt the progress of joint-related risks. Some panelists also raised concerns about unknown long-term risks and how it’s impossible to understand if a given patient will be at risk before taking the treatment.

Panelist Lewis Nelson, chief of the division of medical toxicology at Rutgers New Jersey Medical School, said, “I have serious concerns with the proposed REMS being effective…We don’t know what happens behind closed doors, and even iron-clad REMS with strict guardrails have failed. And this one is a little bit looser than those.”

Steven MeiselMembers of the committees also raised multiple concerns because the drug may be used for many years. The long-term effects of the drug “should not be dismissed, even if you stop it,” added panelist Steven Meisel, system director of medication safety at Fairview Health Services.And although Pfizer has been developing tanezumab for more than 15 years, across 41 clinical studies, multiple panelists sought further information on long-term follow-up.

Jasvinder Singh, committee member and professor of medicine at the University of Alabama at Birmingham, called for a longer-term study with much larger samples, and there would have to be additional insights with regards to the understanding of the pathophysiology and biology of what leads to this rapidly progressing osteoarthritis, which the REMS is meant to help mitigate.

Committee panelist Karim Anton Calis, director of clinical research and compliance office at the NIH, added, “We’re missing information on long-term follow-up, and I don’t think it’s unreasonable to ask for a follow-up study…I wish that had been done.”

Jim Rusnak, chief development officer of internal medicine at Pfizer, told Endpoints News in an emailed statement, “While we are disappointed in today’s outcome, we continue to believe that the clinical data presented for tanezumab supports its benefit-risk profile. 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.”