NEW YORK and INDIANAPOLIS, Indiana—Pfizer Inc. and Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application for tanezumab 2.5 mg, administered subcutaneously.
Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors. The treatment is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA), who have experienced inadequate pain relief with other analgesics. By inhibiting NGF, tanezumab may help to keep pain signals produced by muscles, skin and organs from reaching the spinal cord and brain.
“The FDA acceptance of the tanezumab application represents a significant milestone, and the breadth of our regulatory submission reflects the extensive clinical data we have gathered for tanezumab over the course of its development,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “There is an urgent need for innovation in the treatment of osteoarthritis, as there have been no new classes of medicines available for this debilitating condition in more than a decade. If approved, tanezumab would be a first-in-class treatment for patients suffering from chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics.”
More than 27 million Americans currently live with OA, 11 million of whom have moderate-to-severe OA. Currently available treatment options do not meet the needs of all patients, and many cycle through multiple therapies to find relief from their pain.
“Osteoarthritis patients face a significant burden — due to the physical pain they experience, nearly every aspect of their lives can be impacted. This pain can affect their ability to participate in daily activities, which can have significant psychological, social and societal consequences. We look forward to working closely with the FDA to potentially bring tanezumab to patients living with moderate-to-severe osteoarthritis,” noted Patrik Jonsson, president of Lilly Bio-Medicines.
The tanezumab regulatory submission encompasses data from 39 Phase 1-3 clinical studies evaluating the safety and efficacy of tanezumab among more than 18,000 patients, including three Phase 3 studies evaluating subcutaneous administration of tanezumab in patients with moderate-to-severe OA. To date, tanezumab has not demonstrated a risk of addiction, misuse or dependence. The FDA is expected to make a decision on the tanezumab application in December 2020.