Vutrisiran: Difference between revisions
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== Society and culture == |
== Society and culture == |
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=== Legal status === |
=== Legal status === |
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On 21 July 2022, the [[Committee for Medicinal Products for Human Use]] (CHMP) of the [[European Medicines Agency]] (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Amvuttra, intended for treatment of hereditary transthyretin-mediated (hATTR) amyloidosis.<ref name="Amvuttra: Pending EC decision" /> Amvuttra was designated as an orphan medicinal product on 25 May 2018.<ref name="Amvuttra: Pending EC decision" /> The applicant for this medicinal product is Alnylam Netherlands B.V.<ref name="Amvuttra: Pending EC decision">{{cite web | title=Amvuttra: Pending EC decision | website=European Medicines Agency | date=21 July 2022 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/amvuttra | access-date=30 July 2022}}</ref> Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> |
On 21 July 2022, the [[Committee for Medicinal Products for Human Use]] (CHMP) of the [[European Medicines Agency]] (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Amvuttra, intended for treatment of hereditary transthyretin-mediated (hATTR) amyloidosis.<ref name="Amvuttra: Pending EC decision" /> Amvuttra was designated as an orphan medicinal product on 25 May 2018.<ref name="Amvuttra: Pending EC decision" /> The applicant for this medicinal product is Alnylam Netherlands B.V.<ref name="Amvuttra: Pending EC decision">{{cite web | title=Amvuttra: Pending EC decision | website=European Medicines Agency | date=21 July 2022 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/amvuttra | access-date=30 July 2022 | archive-date=28 July 2022 | archive-url=https://web.archive.org/web/20220728170535/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/amvuttra | url-status=live }}</ref> 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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== References == |
== References == |
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Revision as of 05:08, 30 July 2022
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| Trade names | Amvuttra |
| Other names | ALN-65492 |
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| Routes of administration | Subcutaneous |
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| Legal status | |
| Legal status | |
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Vutrisiran, sold under the brand name Amvuttra, is a medication used for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.[1][2] It is a small interfering RNA (siRNA) that interferes with the expression of the transthyretin (TTR) gene.[3]
Vutrisiran was approved for medical use in the United States in June 2022.[1][2]
Vutrisiran is the international nonproprietary name (INN).[4]
History
The U.S. Food and Drug Administration (FDA) granted the application for vutrisiran orphan drug designation.[5]
Society and culture
Legal status
On 21 July 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Amvuttra, intended for treatment of hereditary transthyretin-mediated (hATTR) amyloidosis.[6] Amvuttra was designated as an orphan medicinal product on 25 May 2018.[6] The applicant for this medicinal product is Alnylam Netherlands B.V.[6] Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
References
- ^ a b c "Amvuttra- vutrisiran injection". DailyMed. 21 June 2022. Archived from the original on 3 July 2022. Retrieved 3 July 2022.
- ^ a b c "Alnylam Announces FDA Approval of Amvuttra (vutrisiran), an RNAi Therapeutic for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults". Alnylam. 13 June 2022. Archived from the original on 14 June 2022. Retrieved 14 June 2022 – via Business Wire.
- ^ Aimo A, Castiglione V, Rapezzi C, Franzini M, Panichella G, Vergaro G, Gillmore J, Fontana M, Passino C, Emdin M (March 2022). "RNA-targeting and gene editing therapies for transthyretin amyloidosis". Nature Reviews. Cardiology. doi:10.1038/s41569-022-00683-z. PMID 35322226. S2CID 247623259.
- ^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl:10665/330896.
- ^ "Vutrisiran Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 25 May 2018. Archived from the original on 14 June 2022. Retrieved 14 June 2022.
- ^ a b c "Amvuttra: Pending EC decision". European Medicines Agency. 21 July 2022. Archived from the original on 28 July 2022. Retrieved 30 July 2022.
External links
- "Vutrisiran". Drug Information Portal. U.S. National Library of Medicine.
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