Tanezumab

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Tanezumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetNerve growth factor (NGF)
Clinical data
Other namesRN624
ATC code
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
Chemical and physical data
FormulaC6464H9942N1706O2026S46
Molar mass145445.32 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Tanezumab (INN, codenamed RN624) is a monoclonal antibody against nerve growth factor as a treatment for pain. Tanezumab was discovered and developed by Rinat Neuroscience[1] and was acquired by Pfizer in 2006.

In 2009 there was a Phase III trial for knee pain due to osteoarthritis (OA).[2] Another Phase III trial for hip pain in OA[3] was halted in June 2010 when some patients needed hip replacement.[4]

Tanezumab is undergoing Phase II clinical trials for the treatment of various pain entities, including chronic low back pain, bone cancer pain, and interstitial cystitis.[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.[6][7]

A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.[8]

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).[9]

Society and culture[edit]

Legal status[edit]

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.[10]

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. [11]

See also[edit]

References[edit]

  1. ^ 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. PMID 15927377. S2CID 36145654.
  2. ^ Clinical trial number NCT00733902 for "Tanezumab in Osteoarthritis of the Knee" at ClinicalTrials.gov
  3. ^ Clinical trial number NCT00744471 for "Tanezumab in Osteoarthritis Of The Hip" at ClinicalTrials.gov
  4. ^ "Trials Halted as Pfizer's Tanezumab Shown to Worsen Osteoarthritis". Genetic Engineering & Biotechnology News. 24 June 2010. Archived from the original on 23 January 2013.
  5. ^ "Phase II trials involving Tanezumab". ClinicalTrials.gov. U.S. National Library of Medicine.
  6. ^ "Tanezumab Arthritis Advisory Committee Briefing Document" (PDF). US Food and Drug Administration. 8 February 2012. Archived from the original (PDF) on 19 January 2017.
  7. ^ Verburg K. "Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain" (PDF). Medicines Development Group, Pfizer Inc. Archived from the original (PDF) on 9 May 2017.
  8. ^ Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR (July 2013). "Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial". Arthritis and Rheumatism. 65 (7): 1795–803. doi:10.1002/art.37950. PMID 23553790.
  9. ^ "Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain". Seeking Alpha. PR Newswire. February 19, 2019.
  10. ^ "Raylumis: Pending EC decision". European Medicines Agency. 17 September 2021. Retrieved 17 September 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. ^ "Transcript for the March 25, 2021 Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee". US Food and Drug administration. 25 March 2021. Retrieved 22 February 2022.

External links[edit]