Joint FDA advisory committee votes against application for tanezumab for the treatment of osteoarthritis pain.- Eli Lilly + Pfizer

Pfizer Inc. and Eli Lilly and Company announced the outcome of the FDA Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on tanezumab. There was a single voting question focused on whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks, and the Committee voted 1 in favor and 19 against. Tanezumab 2.5 mg administered subcutaneously (SC) every eight weeks is being evaluated for the treatment of moderate-to-severe osteoarthritis (OA) pain in adult patients for whom use of other analgesics is ineffective or not appropriate. Tanezumab is an investigational monoclonal antibody in a new class of medicines called nerve growth factor (NGF) inhibitors, which work in a different manner than currently available treatments such as opioids, nonsteroidal anti-inflammatory drugs (NSAIDs) and other analgesics. In studies to date, tanezumab has not demonstrated a risk of addiction, misuse or dependence.