Content deleted Content added
Citation bot (talk | contribs) Removed parameters. | Use this bot. Report bugs. | Suggested by AManWithNoPlan | #UCB_CommandLine |
templates |
||
| (3 intermediate revisions by 2 users not shown) | |||
Line 2:
{{Use American English|date=February 2022}}
{{Use dmy dates|date=November 2019}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Infobox drug
| image =
Line 19 ⟶ 20:
| routes_of_administration = [[Subcutaneous injection|Subcutaneous]]
| class =
| ATC_prefix = A16
| ATC_suffix = AX16
Line 26:
<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment = <ref name="Givlaari APMDS">{{cite web | title=Givlaari APMDS | website=Therapeutic Goods Administration (TGA) | date=15 December 2023 | url=https://www.tga.gov.au/resources/auspmd/givlaari | access-date=7 March 2024 | archive-date=2 January 2024 | archive-url=https://web.archive.org/web/20240102015555/https://www.tga.gov.au/resources/auspmd/givlaari | url-status=live }}</ref>
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = <ref>{{cite web | title=Summary Basis of Decision (SBD) for Givlaari | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00514&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530051132/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00514&lang=en | url-status=live }}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE_comment =
Line 38:
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Givlaari FDA label">{{cite web | title=Givlaari- givosiran sodium injection, solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=167e663c-11e1-497b-a3fc-951d65d58eaa | access-date=7 February 2022 | archive-date=8 February 2022 | archive-url=https://web.archive.org/web/20220208000540/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=167e663c-11e1-497b-a3fc-951d65d58eaa | url-status=live }}</ref>
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Givlaari EPAR">{{cite web | title=Givlaari EPAR | website=European Medicines Agency | date=29 January 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/givlaari | access-date=4 March 2023 | archive-date=12 November 2021 | archive-url=https://web.archive.org/web/20211112125438/https://www.ema.europa.eu/en/medicines/human/EPAR/givlaari | url-status=live }}</ref><ref>{{cite web | title=Givlaari Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1428.htm | access-date=3 March 2023 | archive-date=5 March 2023 | archive-url=https://web.archive.org/web/20230305070955/https://ec.europa.eu/health/documents/community-register/html/h1428.htm | url-status=live }}</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment =
Line 95:
<!-- History and culture -->
The U.S. [[Food and Drug Administration]] (FDA) considers it to be a [[first-in-class medication]].<ref>{{cite web | title=New Drug Therapy Approvals 2019 | website=U.S. Food and Drug Administration | date=31 December 2019 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019 | access-date=15 September 2020 | archive-date=18 January 2024 | archive-url=https://web.archive.org/web/20240118203546/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019 | url-status=live }}</ref>
== Medical uses ==
Line 101:
== History ==
In November 2019, givosiran was approved in the United States for the treatment of adults with acute hepatic porphyria (AHP).<ref name="FDA PR" /><ref name="FDA Snapshot">{{cite web | title=Drug Trials Snapshots: Givlaari | website=U.S. [[Food and Drug Administration]] (FDA) | date=20 November 2019 | url=http://www.fda.gov/drugs/drug-trials-snapshots-givlaari | access-date=24 January 2020 | archive-date=24 January 2020 | archive-url=https://web.archive.org/web/20200124191448/https://www.fda.gov/drugs/drug-trials-snapshots-givlaari | url-status=live }} {{PD-notice}}</ref>
Efficacy was evaluated in ENVISION (NCT03338816), a randomized, double‑blind, placebo‑controlled, multinational trial enrolling 94 participants with acute hepatic porphyria.<ref name="FDA PR 20191120" /> Participants were randomized (1:1) to receive once monthly subcutaneous injections of givosiran 2.5 mg/kg or placebo during a six‑month double‑blind period.<ref name="FDA PR 20191120" /> The performance of givosiran was measured by the rate of porphyria attacks that required hospitalizations, urgent health care visits or intravenous infusion of hemin at home.<ref name="FDA PR" /> Participants who received givosiran experienced 70% fewer porphyria attacks compared to patients receiving a placebo.<ref name="FDA PR" />
Line 115:
{{Other alimentary tract and metabolism products}}
{{Portal bar | Medicine}}
{{Authority control}}
[[Category:Orphan drugs]]
[[Category:small interfering RNA]]
| |||