Tanezumab Explained

Tanezumab (INN, codenamed RN624) is a monoclonal antibody against nerve growth factor as a treatment for pain via a novel mechanisms different from conventional pain-killer drugs.[1] Tanezumab was discovered and developed by Rinat Neuroscience[2] and was acquired by Pfizer in 2006.

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

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.[4]

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.[5] [6]

A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.[7]

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).[8]

Society and culture

Legal status

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.[9]

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. [10]

See also

External links

Notes and References

  1. Oo WM, Hunter DJ . Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review . BioDrugs . 35 . 6 . 611–641 . November 2021 . 34807432 . 10.1007/s40259-021-00504-8 . 244509341 .
  2. Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A . Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis . Pain . 116 . 1–2 . 8–16 . July 2005 . 15927377 . 10.1016/j.pain.2005.03.039 . 36145654 .
  3. Web site: Trials Halted as Pfizer's Tanezumab Shown to Worsen Osteoarthritis . 24 June 2010 . Genetic Engineering & Biotechnology News . https://web.archive.org/web/20130123043725/http://www.genengnews.com/gen-news-highlights/trials-halted-as-pfizer-s-tanezumab-shown-to-worsen-osteoarthritis/81243572/ . 23 January 2013 .
  4. Web site: Phase II trials involving Tanezumab . ClinicalTrials.gov . U.S. National Library of Medicine .
  5. Web site: Tanezumab Arthritis Advisory Committee Briefing Document . 8 February 2012 . US Food and Drug Administration . https://web.archive.org/web/20170119055305/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM295205.pdf . 19 January 2017 .
  6. Web site: Verburg K . Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain . Medicines Development Group, Pfizer Inc. . https://web.archive.org/web/20170509180502/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM301305.pdf . 9 May 2017 .
  7. Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR . Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial . Arthritis and Rheumatism . 65 . 7 . 1795–1803 . July 2013 . 23553790 . 10.1002/art.37950 . free .
  8. Web site: Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain . February 19, 2019 . PR Newswire . Seeking Alpha.
  9. Web site: Raylumis: Pending EC decision . European Medicines Agency . 17 September 2021 . 17 September 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  10. Web site: 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 . 22 February 2022 .

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