Chemistry:Tanezumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | Nerve growth factor (NGF) |
| Clinical data | |
| Other names | RN624 |
| ATC code | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| Chemical and physical data | |
| Formula | C6464H9942N1706O2026S46 |
| Molar mass | 145445.32 g·mol−1 |
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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).[3] Another Phase III trial for hip pain in OA[4] was halted in June 2010 when some patients needed hip replacement.[5]
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.[6]
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]
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.[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]
See also
References
- ↑ "Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review". BioDrugs 35 (6): 611–641. November 2021. doi:10.1007/s40259-021-00504-8. PMID 34807432.
- ↑ "Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis". Pain 116 (1–2): 8–16. July 2005. doi:10.1016/j.pain.2005.03.039. PMID 15927377.
- ↑ Clinical trial number NCT00733902 for "Tanezumab in Osteoarthritis of the Knee" at ClinicalTrials.gov
- ↑ Clinical trial number NCT00744471 for "Tanezumab in Osteoarthritis Of The Hip" at ClinicalTrials.gov
- ↑ "Trials Halted as Pfizer's Tanezumab Shown to Worsen Osteoarthritis". Genetic Engineering & Biotechnology News. 24 June 2010. http://www.genengnews.com/gen-news-highlights/trials-halted-as-pfizer-s-tanezumab-shown-to-worsen-osteoarthritis/81243572/.
- ↑ "Phase II trials involving Tanezumab". ClinicalTrials.gov. U.S. National Library of Medicine. http://www.clinicaltrials.gov/ct2/results?term=Tanezumab&phase=1.
- ↑ "Tanezumab Arthritis Advisory Committee Briefing Document". US Food and Drug Administration. 8 February 2012. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM295205.pdf.
- ↑ "Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain". Medicines Development Group, Pfizer Inc.. https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/arthritisadvisorycommittee/ucm301305.pdf.
- ↑ "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. doi:10.1002/art.37950. PMID 23553790.
- ↑ "Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain". PR Newswire. February 19, 2019. https://seekingalpha.com/pr/17415547-pfizer-lilly-announce-top-line-results-phase-3-study-tanezumab-chronic-low-back-pain.
- ↑ "Raylumis: Pending EC decision". 17 September 2021. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/raylumis. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Transcript for the March 25, 2021 Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee". 25 March 2021. https://www.fda.gov/media/150663/download.
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