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Revision as of 03:33, 20 October 2022
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| Trade names | Amvuttra |
| Other names | ALN-65492 |
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| Routes of administration | Subcutaneous |
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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][3] It is a small interfering RNA (siRNA) that interferes with the expression of the transthyretin (TTR) gene.[4]
Vutrisiran was approved for medical use in the United States in June 2022,[1][3] and in the European Union in September 2022.[2]
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] Vutrisiran was approved for medical use in the European Union in September 2022.[2]
Names
Vutrisiran is the international nonproprietary name (INN).[7]
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 "Amvuttra EPAR". European Medicines Agency. 18 July 2022. Retrieved 13 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "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.
- ^ "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. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl:10665/330896.
External links
- "Vutrisiran". Drug Information Portal. U.S. National Library of Medicine.
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