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Oxlumo FDA Approval History

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 Type 1 (PH1)

Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary 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

DateArticle
Nov 24, 2020ApprovalFDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1
Jun  7, 2020Alnylam Presents Positive Phase 3 Results from ILLUMINATE-A Study of Lumasiran, an Investigational RNAi Therapeutic for Treatment of Primary Hyperoxaluria Type 1
Apr  7, 2020Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1
Jan 10, 2020Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
Dec 17, 2019Alnylam Reports Positive Topline Results from ILLUMINATE-A Phase 3 Study of Lumasiran for the Treatment of Primary Hyperoxaluria Type 1
Nov  9, 2019Alnylam Initiates ILLUMINATE-C Phase 3 Study of Lumasiran for the Treatment of Advanced Primary Hyperoxaluria Type 1 and Presents New Positive Results from Phase 2 Open-Label Extension Study
Jun  8, 2018Alnylam Reports Updated Positive Results from Phase 1/2 Study of Lumasiran in Patients with Primary Hyperoxaluria Type 1 (PH1)
May  3, 2018Alnylam Achieves Alignment with FDA on Accelerated Development Path for Lumasiran, an Investigational RNAi Therapeutic for the Treatment of Primary Hyperoxaluria Type 1 (PH1)

Further information

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