Denosumab: Perbedaan antara revisi

Pada bulan Agustus 2009, diadakan pertemuan antara Amgen dan Komite Penasihat Obat Kesehatan Reproduksi (ACRHD) dari [[Badan Pengawas Obat dan Makanan ASAmerika Serikat]] (FDA) untuk meninjau potensi penggunaan denosumab.[25]<ref>{{cite web |title=Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting |publisher=PRNewswire/FirstCall |date=13 August 2009 |url=http://www.urotoday.com/3401/browse_categories/prostate_cancer/amgen_issues_statement_on_outcomes_of_advisory_committee_for_reproductive_health_drugs_acrhd_meeting08192009.html |access-date=17 September 2009 |archive-url=https://web.archive.org/web/20131103205109/http://www.urotoday.com/3401/browse_categories/prostate_cancer/amgen_issues_statement_on_outcomes_of_advisory_committee_for_reproductive_health_drugs_acrhd_meeting08192009.html |archive-date=3 November 2013 |url-status=dead }}</ref>

Pada bulan Oktober 2009, FDA menunda persetujuan denosumab, dengan alasan bahwa FDA memerlukan informasi lebih lanjut.<ref>{{cite news|url=https://www.nytimes.com/2009/10/20/business/20amgen.html|work=[26[The New York Times]]|title=F.D.A. Says No to an Amgen Bone Drug|date=19 October 2009|last=Pollack|first=Andrew|access-date=24 February 2017|archive-date=27 January 2018|archive-url=https://web.archive.org/web/20180127135657/http://www.nytimes.com/2009/10/20/business/20amgen.html|url-status=live}}</ref>

Pada bulan Juni 2010, denosumab disetujui oleh FDA untuk digunakan pada wanita pascamenopause dengan risiko osteoporosis[27]<ref name=FDA-deno/> dengan merek dagang Prolia,[28]<ref>{{cite web |url=http://www.biosciencetechnology.com/News/FeedsAP/2010/06/fda-clears-amgens-bone-strengthening-drug-prolia/ |title=FDA clears Amgen's bone-strengthening drug Prolia |author=Matthew Perrone |publisher=BioScience Technology |date=2 June 2010 |access-date=2 June 2010 |archive-url=https://web.archive.org/web/20100827180700/http://www.biosciencetechnology.com/News/FeedsAP/2010/06/fda-clears-amgens-bone-strengthening-drug-prolia/ |archive-date=27 August 2010 |url-status=dead }}</ref> dan pada bulan November 2010 sebagai Xgeva untuk pencegahan kejadian terkait kerangka pada orang dengan metastasis tulang dari [[neoplasma|tumor]] padat.[29]<ref name=Nov2010>{{cite news |url=http://www.genengnews.com/gen-news-highlights/amgen-s-denosumab-cleared-by-fda-for-second-indication/81244270/ |title=Amgen's Denosumab Cleared by FDA for Second Indication |date=19 November 2010 |access-date=27 November 2010 |archive-date=7 April 2018 |archive-url=https://web.archive.org/web/20180407054018/https://www.genengnews.com/gen-news-highlights/amgen-s-denosumab-cleared-by-fda-for-second-indication/81244270/ |url-status=dead }}</ref> Denosumab adalah inhibitorpenghambat RANKL pertama yang disetujui oleh FDA.[<ref name=FDA-deno>{{cite news |url=http://www.medpagetoday.com/Endocrinology/Osteoporosis/20432 |title=FDA Approves Denosumab for Osteoporosis |date=2 June 2010 |access-date=27] November 2010 |archive-date=13 June 2018 |archive-url=https://web.archive.org/web/20180613015439/https://www.medpagetoday.com/endocrinology/osteoporosis/20432 |url-status=live }}</ref>

Pada bulan Juni 2013, FDA menyetujui denosumab untuk pengobatan orang dewasa dan remaja yang sudah matang secara skeletal dengan tumor sel raksasa tulang yang tidak dapat direseksi atau yang reseksinya akan mengakibatkan morbiditas yang signifikan.[30]<ref>{{cite web|url=http://www.cancer.gov/cancertopics/druginfo/fda-denosumab|title=FDA Approval for Denosumab|access-date=31 August 2013|archive-date=6 April 2015|archive-url=https://web.archive.org/web/20150406011426/http://www.cancer.gov/cancertopics/druginfo/fda-denosumab|url-status=dead}}</ref>

Pada bulan Januari 2024, FDA menambahkan peringatan kotak hitam untuk Prolia karena risiko hipokalsemia parah pada mereka yang memiliki penyakit ginjal lanjut. Tinjauan FDA menemukan bahwa Prolia telah mengakibatkan "rawat inap, kejadian yang mengancam jiwa, dan kematian" pada populasi tersebut.<ref>"[31https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-drug-safety-communication-fda-adds-boxed-warning-increased-risk-severe-hypocalcemia Prolia (denosumab): Drug Safety Communication - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease] {{Webarchive|url=https://web.archive.org/web/20240406170114/https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-drug-safety-communication-fda-adds-boxed-warning-increased-risk-severe-hypocalcemia |date=6 April 2024 }}". U.S. Food and Drug Administration, 19 January 2024.</ref>