Oxlumo FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 12, 2022.
FDA Approved: Yes (First approved November 23, 2020)
Brand name: Oxlumo
Generic name: lumasiran
Dosage form: Injection
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Primary Hyperoxaluria
Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.
- Oxlumo works by degrading HAO1 messenger RNA and reducing the synthesis of glycolate oxidase, which inhibits hepatic production of oxalate - the toxic metabolite responsible for the clinical manifestations of PH1.
- Oxlumo is administered by subcutaneous injection once a month for three months, then monthly for patients weighing less than 10 kg, and quarterly for patients weighing more than 10 kg.
- The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.
Development timeline for Oxlumo
Further information
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