Pfizer Inc and Eli Lilly today announced the outcome of the U.S. Food and Drug Administration (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.
“While we are disappointed with today’s outcome, we continue to believe that tanezumab has a positive benefit-risk profile for patients with moderate-to-severe osteoarthritis pain for whom current treatments are ineffective or not appropriate. Many of these patients have exhausted available therapies, have not had a new class of medications available to them in more than a decade and are eager for new, non-opioid options,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “We will continue to work with the FDA as the agency continues its review of our application.”
The Advisory Committee’s discussions were based on the Biologics License Application (BLA) currently under review by the FDA. The BLA includes data from 20 Phase 1-3 clinical studies evaluating the safety and efficacy of tanezumab administered intravenously or SC in patients with OA, including three pivotal Phase 3 SC studies involving more than 4,500 patients with moderate-to-severe OA.
“The dialogue during the open public forum of this week’s Advisory Committee meeting reinforced the urgent need for innovation for people living with moderate-to-severe osteoarthritis pain – many of whom cycle through three to four therapies each year without adequate relief. The unresolved pain can impact all aspects of their lives, creating physical, emotional, social and financial hardships,” said Ilya Yuffa, president, Lilly Bio-Medicines.
Advisory Committees provide the FDA with independent opinions and recommendations from outside medical experts during the regulatory review process; however, the recommendations are not binding.
