Nedosiran
Medication
From Wikipedia, the free encyclopedia
Nedosiran, sold under the brand name Rivfloza, is a medication used for the treatment of primary hyperoxaluria.[1] It is an LDHA-directed small interfering RNA developed by Dicerna Pharmaceuticals.[1][2]
| Clinical data | |
|---|---|
| Trade names | Rivfloza |
| Other names | DCR-PHXC |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
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The most common side effects include injection site reactions.[3]
Nedosiran was approved for medical use in the United States in September 2023.[1][4][5][3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[6]
Medical uses
History
The US FDA approved nedosiran based on evidence from a clinical trial which included 29 participants with primary hyperoxaluria type 1.[3] Nedosiran was evaluated in one clinical trial of 29 participants with primary hyperoxaluria type 1 who were nine years of age and older.[3] Participants randomly received either nedosiran or placebo injections once a month for six months.[3] Neither the participants nor the healthcare providers knew which treatment was being given.[3] 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.[3]
Society and culture
Legal status
The FDA granted the application for nedosiran breakthrough therapy and orphan drug designations.[6] Nedosiran was approved for medical use in the United States in September 2023.[1][3]
Names
Nedosiran is the international nonproprietary name.[7]
