The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for tanezumab (Pfizer and Lilly) 2.5mg administered subcutaneously for moderate to severe osteoarthritis (OA) pain.
Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF). The BLA is supported by data from 39 clinical studies, including three phase 3 studies (NCT02697773, NCT02709486, NCT02528188) that evaluated the efficacy and safety of tanezumab in patients with moderate to severe OA of the knee or hip. Studies NCT02697773 and NCT02709486 compared tanezumab (2.5mg and 5mg) with placebo; and study NCT02528188 compared tanezumab (2.5mg and 5mg) with oral nonsteroidal anti-inflammatory drugs (NSAIDs).
Results from NCT02697773 showed patients in both tanezumab treatment groups experienced a statistically significant improvement in pain, physical function, and overall assessment of OA. In NCT02709486, a statistically significant improvement in pain and physical function was observed in patients treated with tanezumab 2.5mg and 5mg compared with placebo; as for the patient’s global assessment of OA, a statistically significant difference was only noted in the tanezumab 5mg arm.
Findings from NCT02528188 showed that tanezumab 5mg was associated with a statistically significant improvement in pain and physical function compared with NSAIDs, however patient’s overall assessment of OA was not statistically different from NSAIDs; the tanezumab 2.5mg group did not meet any of the 3 efficacy end points. As for safety, treatment with tanezumab was associated with a statistically significantly higher rate of joint safety events (composite measure) compared with NSAIDs at 80 weeks (7.1% for tanezumab 5mg, 3.8% for tanezumab 2.5mg, and 1.5% for NSAIDs).
The Prescription Drug User Fee Act (PDUFA) target action date has been set for December 2020 for the application.