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Latest revision as of 02:39, 16 July 2024 edit undoWhywhenwhohow (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers49,185 edits update refs |
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'''Tanezumab''' (], codenamed '''RN624''') is a ] against ] as a treatment for pain via a novel mechanisms different from conventional pain-killer drugs.<ref>{{Cite journal |last1=Oo |first1=Win Min |last2=Hunter |first2=David J. |date=2021-11-01 |title=Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review |url=https://doi.org/10.1007/s40259-021-00504-8 |journal=BioDrugs |language=en |volume=35 |issue=6 |pages=611–641 |doi=10.1007/s40259-021-00504-8 |pmid=34807432 |s2cid=244509341 |issn=1179-190X}}</ref> Tanezumab was discovered and developed by ]<ref>{{cite journal | vauthors = Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A | title = Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis | journal = Pain | volume = 116 | issue = 1–2 | pages = 8–16 | date = July 2005 | pmid = 15927377 | doi = 10.1016/j.pain.2005.03.039 | s2cid = 36145654 | url = https://www.semanticscholar.org/paper/6796f206cbe754eb27de18b403f5dcf324e8207e }}</ref> and was acquired by ] in 2006. |
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'''Tanezumab''' (], codenamed '''RN624''') is a ] against ] as a treatment for pain via a novel mechanisms different from conventional pain-killer drugs.<ref>{{cite journal | vauthors = Oo WM, Hunter DJ | title = Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review | journal = BioDrugs | volume = 35 | issue = 6 | pages = 611–641 | date = November 2021 | pmid = 34807432 | doi = 10.1007/s40259-021-00504-8 | s2cid = 244509341 }}</ref> Tanezumab was discovered and developed by ]<ref>{{cite journal | vauthors = Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A | title = Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis | journal = Pain | volume = 116 | issue = 1–2 | pages = 8–16 | date = July 2005 | pmid = 15927377 | doi = 10.1016/j.pain.2005.03.039 | s2cid = 36145654 }}</ref> and was acquired by ] in 2006. |
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In 2009 there was a ] trial for knee pain due to ].<ref>{{ClinicalTrialsGov|NCT00733902|Tanezumab in Osteoarthritis of the Knee}}</ref> |
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In 2009 there was a ] trial for knee pain due to ].<ref>{{ClinicalTrialsGov|NCT00733902|Tanezumab in Osteoarthritis of the Knee}}</ref> |
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Tanezumab is undergoing ] clinical trials for the treatment of various pain entities, including chronic low back pain, ], and ].<ref>{{cite web |url=http://www.clinicaltrials.gov/ct2/results?term=Tanezumab&phase=1 |title=Phase II trials involving Tanezumab | work = ClinicalTrials.gov | publisher = U.S. National Library of Medicine }}</ref> |
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Tanezumab is undergoing ] clinical trials for the treatment of various pain entities, including chronic low back pain, ], and ].<ref>{{cite web |url=http://www.clinicaltrials.gov/ct2/results?term=Tanezumab&phase=1 |title=Phase II trials involving Tanezumab | work = ClinicalTrials.gov | publisher = U.S. National Library of Medicine }}</ref> |
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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.<ref>{{cite web | title = Tanezumab Arthritis Advisory Committee Briefing Document | date = 8 February 2012 | publisher = US Food and Drug Administration | url = https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM295205.pdf | archive-url = https://web.archive.org/web/20170119055305/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM295205.pdf | archive-date = 19 January 2017 }}</ref><ref>{{cite web | first = Ken | last = Verburg | name-list-style = vanc | title = Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain | work = Medicines Development Group, Pfizer Inc. | url = https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/arthritisadvisorycommittee/ucm301305.pdf | archive-url = https://web.archive.org/web/20170509180502/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM301305.pdf | archive-date = 9 May 2017 }}</ref> |
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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.<ref>{{cite web | title = Tanezumab Arthritis Advisory Committee Briefing Document | date = 8 February 2012 | publisher = US Food and Drug Administration | url = https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM295205.pdf | archive-url = https://web.archive.org/web/20170119055305/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM295205.pdf | archive-date = 19 January 2017 }}</ref><ref>{{cite web | vauthors = Verburg K | title = Monoclonal Antibodies Targeted Against Nerve Growth Factor For the Treatment of Chronic Pain | work = Medicines Development Group, Pfizer Inc. | url = https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/arthritisadvisorycommittee/ucm301305.pdf | archive-url = https://web.archive.org/web/20170509180502/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM301305.pdf | archive-date = 9 May 2017 }}</ref> |
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A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.<ref>{{cite journal | vauthors = Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR | title = Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial | journal = Arthritis and Rheumatism | volume = 65 | issue = 7 | pages = 1795–803 | date = July 2013 | pmid = 23553790 | doi = 10.1002/art.37950 | doi-access = free }}</ref> |
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A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.<ref>{{cite journal | vauthors = Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR | title = Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial | journal = Arthritis and Rheumatism | volume = 65 | issue = 7 | pages = 1795–1803 | date = July 2013 | pmid = 23553790 | doi = 10.1002/art.37950 | doi-access = free }}</ref> |
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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).<ref>{{cite web|url=https://seekingalpha.com/pr/17415547-pfizer-lilly-announce-top-line-results-phase-3-study-tanezumab-chronic-low-back-pain|title=Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain | date = February 19, 2019 | publisher = PR Newswire |website=Seeking Alpha}}</ref> |
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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).<ref>{{cite web|url=https://seekingalpha.com/pr/17415547-pfizer-lilly-announce-top-line-results-phase-3-study-tanezumab-chronic-low-back-pain|title=Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain | date = February 19, 2019 | publisher = PR Newswire |website=Seeking Alpha}}</ref> |
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== Society and culture == |
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== Society and culture == |
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=== Legal status === |
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=== Legal status === |
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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.<ref>{{cite web | title=Raylumis: Pending EC decision | website=European Medicines Agency | date=17 September 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/raylumis | access-date=17 September 2021}} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> |
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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.<ref>{{cite web | title=Raylumis: Pending EC decision | website=European Medicines Agency | date=17 September 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/raylumis | access-date=17 September 2021}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> |
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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. <ref>{{cite web | title= Transcript for the March 25, 2021 Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee | website=US Food and Drug administration | date=25 March 2021 | url = https://www.fda.gov/media/150663/download | access-date=22 February 2022 }}</ref> |
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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. <ref>{{cite web | title= Transcript for the March 25, 2021 Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee | website=US Food and Drug administration | date=25 March 2021 | url = https://www.fda.gov/media/150663/download | access-date=22 February 2022 }}</ref> |
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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.
A Phase III trial published in 2013 found tanezumab was superior to placebo for painful hip osteoarthritis.
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).
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.
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.
