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| routes_of_administration = [[Subcutaneous administration|Subcutaneous]]
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| ATC_prefix = None <!-- Scheduled to be A16AX25 in 2025 -->
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'''Nedosiran''', sold under the brand name '''Rivfloza''', is a [[medication]] used for the treatment of [[primary hyperoxaluria]].<ref name="Rivfloza FDA label" /> It is an [[Lactate dehydrogenase A|LDHA]]-directed [[small interfering RNA]] developed by Dicerna Pharmaceuticals.<ref name="Rivfloza FDA label" /><ref>{{cite web | title=Nedosiran | website=Dicerna Pharmaceuticals | date=17 August 2021 | url=https://dicerna.com/pipeline/nedosiran/ | access-date=1 October 2023 | archive-date=26 July 2023 | archive-url=https://web.archive.org/web/20230726061616/https://dicerna.com/pipeline/nedosiran/ | url-status=live }}</ref>
The most common side effects include injection site reactions.<ref name="Rivfloza FDA snapshot" />
Nedosiran was approved for medical use in the United States in September 2023.<ref name="Rivfloza FDA label" /><ref>{{cite web | title=Rivfloza: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215842 | access-date=1 October 2023 | archive-date=2 October 2023 | archive-url=https://web.archive.org/web/20231002035105/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215842 | url-status=live }}</ref><ref name="Drug Approval Package: Rivfloza">{{cite web | title=Drug Approval Package: Rivfloza | website=U.S. [[Food and Drug Administration]] (FDA) | date=18 October 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215842Orig1s000TOC.cfm | access-date=10 January 2024}}</ref> The US [[Food and Drug Administration]] (FDA) considers it to be a [[first-in-class medication]].<ref name="New Drug Therapy Approvals 2023">{{cite report | title=New Drug Therapy Approvals 2023 | website=U.S. [[Food and Drug Administration]] (FDA) | date=January 2024 | url=https://www.fda.gov/media/175253/download | format=PDF | access-date=9 January 2024 | archive-url=https://web.archive.org/web/20240110032419/https://www.fda.gov/media/175253/download | archive-date=10 January 2024 | url-status=live }}</ref>▼
▲Nedosiran was approved for medical use in the United States in September 2023.<ref name="Rivfloza FDA label" /><ref>{{cite web | title=Rivfloza: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215842 | access-date=1 October 2023 | archive-date=2 October 2023 | archive-url=https://web.archive.org/web/20231002035105/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215842 | url-status=live }}</ref><ref name="Drug Approval Package: Rivfloza">{{cite web | title=Drug Approval Package: Rivfloza | website=U.S. [[Food and Drug Administration]] (FDA) | date=18 October 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215842Orig1s000TOC.cfm | access-date=10 January 2024}}</ref><ref name="Rivfloza FDA snapshot">{{cite web | title=Drug Trials Snapshots: Rivfloza | website=U.S. [[Food and Drug Administration]] (FDA) | date=29 September 2023 | url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rivfloza | access-date=15 July 2024}} {{PD-notice}}</ref> The US [[Food and Drug Administration]] (FDA) considers it to be a [[first-in-class medication]].<ref name="New Drug Therapy Approvals 2023">{{cite report | title=New Drug Therapy Approvals 2023 | website=U.S. [[Food and Drug Administration]] (FDA) | date=January 2024 | url=https://www.fda.gov/media/175253/download | format=PDF | access-date=9 January 2024 | archive-url=https://web.archive.org/web/20240110032419/https://www.fda.gov/media/175253/download | archive-date=10 January 2024 | url-status=live }}</ref>
== Medical uses ==
Nedosiran is [[indicated]] to lower urinary [[oxalate]] levels in people nine years of age and older with primary hyperoxaluria type 1 and relatively preserved kidney function.<ref name="Rivfloza FDA label" /><ref name="Rivfloza FDA snapshot" />
== History ==
The US FDA approved nedosiran based on evidence from a clinical trial which included 29 participants with primary hyperoxaluria type 1.<ref name="Rivfloza FDA snapshot" /> Nedosiran was evaluated in one clinical trial of 29 participants with primary hyperoxaluria type 1 who were nine years of age and older.<ref name="Rivfloza FDA snapshot" /> Participants randomly received either nedosiran or placebo injections once a month for six months.<ref name="Rivfloza FDA snapshot" /> Neither the participants nor the healthcare providers knew which treatment was being given.<ref name="Rivfloza FDA snapshot" /> The benefit of nedosiran was assessed by measuring the amount of oxalate in the urine and comparing it to placebo. The trial was conducted at 19 sites in 11 countries in North America, Europe, Asia, and Australia.<ref name="Rivfloza FDA snapshot" />
== Society and culture ==
=== Legal status ===
The FDA granted the application for nedosiran [[breakthrough therapy]] and [[orphan drug]] designations.<ref name="New Drug Therapy Approvals 2023" /> Nedosiran was approved for medical use in the United States in September 2023.<ref name="Rivfloza FDA label" /><ref name="Rivfloza FDA snapshot" />
=== Names ===
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