FDA joint adcom returns negative vote on tanezumab for osteo pain

Perhaps not surprisingly, given negative briefing documents, the US Food and Drug Administration joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on tanezumab voted against the benefits of the drug to treat osteoarthritis pain, under development at US pharma majors Pfizer: PFE) and Eli Lilly (NYSE: LLY).

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, the companies noted.

Tanezumab 2.5mg 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, non-steroidal anti-inflammatory drugs (NSAIDs) and other analgesics. In studies to date, tanezumab has not demonstrated a risk of addiction, misuse or dependence.