The application to the FDA included data from 39 clinical studies that evaluated the safety and efficacy of tanezumab in more than 18,000 patients. Included were three phase 3 clinical trials that evaluated the efficacy of tanezumab administration in patients with moderate to severe OA. The overall joint safety will most likely be a determining factor for FDA review. To date, tanezumab has not demonstrated a risk of addiction, misuse or dependence in any studies. The fate of tanezumab remains to be seen.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
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References
- Eli Lilly & Company. News release: U.S. FDA accepts regulatory submission for tanezumab, a potential first-in-class treatment for patients with chronic pain due to moderate to severe osteoarthritis. 2020 Mar 2.
- Hochberg M, Carrino J, Schnitzer T, et al. Subcutaneous tanezumab versus NSAID for the treatment of osteoarthritis: Joint safety events in a randomized, double-blind, active-controlled, 80-week, phase 3 study [abstract]. Arthritis Rheumatol. 2019;71 (suppl 10).
- Schnitzer TJ, Easton R, Pang S, et al. Effect of tanezumab on joint pain, physical function and patient global assessment of osteoarthritis among patients with osteoarthritis of the hip or knee—A randomized clinical trial. JAMA. 2019 Jul 2;322(1):37–48.
- Katz JN. Tanezumab for painful osteoarthritis. JAMA. 2019 Jul 2;322(1):30–32.
