In 2009 there was aPhase III trial for knee pain due toosteoarthritis (OA).[3]Another Phase III trial for hip pain in OA[4] was halted in June 2010 when some patients needed hip replacement.[5]
In March 2012, the Anti-NGF Testing - FDA Committee voted in favor of a continuation of the development of nerve-blocking medications, as long as certain safety precautions were observed.[7][8]
A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.[9]
At February 19, 2019 the co-development partners - Eli Lilly and Pfizer - announced that treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in chronic low back pain at 16 weeks compared to placebo (however, 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis).[10]
On 16 September 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for tanezumab (Raylumis), a medicine intended for the treatment of pain associated with osteoarthritis.[11]
On 25 March 2021, the FDA Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 1 to 19 against the question : on whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks.[12]
^Oo WM, Hunter DJ (November 2021). "Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review".BioDrugs.35 (6):611–641.doi:10.1007/s40259-021-00504-8.PMID34807432.S2CID244509341.
^Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A (July 2005). "Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis".Pain.116 (1–2):8–16.doi:10.1016/j.pain.2005.03.039.PMID15927377.S2CID36145654.
^"Raylumis: Pending EC decision".European Medicines Agency. 17 September 2021. Retrieved17 September 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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