Alnylam's Oxlumo (lumasiran) Receives the US FDA's Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients
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- 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
Ref: Businesswire | Image: Bloomberg
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