Comments for the FDA’s March 24-25, 2021 Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Biologics License Application for the Osteoarthritis Drug Tanezumab
Public Citizen urges the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to recommend that the Food and Drug Administration (FDA) not approve the biologics license application for tanezumab because the totality of the evidence from three published pivotal phase 3 randomized clinical trials demonstrates that the drug fails to provide clinically meaningful benefit but does dramatically increase the rates of rapidly progressive osteoarthritis and other types of serious joint damage and of total joint replacements in a dose- and duration-dependent manner. As a result, the serious risks of the drug far outweigh its benefits.
See Public Citizen’s other work on the anti-nerve growth factor drug tanezumab.