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
|Oct 7, 2022||Approval Alnylam Announces FDA Approval of Supplemental New Drug Application for Oxlumo (lumasiran) in Advanced Primary Hyperoxaluria Type 1|
|Nov 24, 2020||Approval FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1|
|Jun 7, 2020||Alnylam Presents Positive Phase 3 Results from ILLUMINATE-A Study of Lumasiran, an Investigational RNAi Therapeutic for Treatment of Primary Hyperoxaluria Type 1|
|Apr 7, 2020||Alnylam 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, 2020||Alnylam 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, 2019||Alnylam Reports Positive Topline Results from ILLUMINATE-A Phase 3 Study of Lumasiran for the Treatment of Primary Hyperoxaluria Type 1|
|Nov 9, 2019||Alnylam 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, 2018||Alnylam Reports Updated Positive Results from Phase 1/2 Study of Lumasiran in Patients with Primary Hyperoxaluria Type 1 (PH1)|
|May 3, 2018||Alnylam Achieves Alignment with FDA on Accelerated Development Path for Lumasiran, an Investigational RNAi Therapeutic for the Treatment of Primary Hyperoxaluria Type 1 (PH1)|
|Nov 3, 2017||Alnylam Reports Positive Preliminary Results from Ongoing Phase 1/2 Study of Lumasiran (ALN-GO1) in Patients with Primary Hyperoxaluria Type 1 (PH1)|
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