Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Shots:

• The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients
• The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to PBO, the study also achieved significant results for all 6 tested 2EPs
• In ILLUMINATE-B, Oxlumo demonstrated a 72% mean reduction in spot urinary oxalate: creatinine ratio from baseline to 6mos., reduction of oxalate as consistent across all three body wt. categories. Additionally, therapy demonstrated positive results across 2EPs, including additional measures of oxalate

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