Alnylam Reports the US FDA’s Acceptance of sNDA Application Filed for Oxlumo to Treat Advanced Primary Hyperoxaluria
Shots:
- The approval was based on the P-III (ILLUMINATE-C) clinical trial evaluating the safety & efficacy of Oxlumo in adult & pediatric PH1 patients with severe renal impairment incl. those on hemodialysis
- The results from the study demonstrated a reduction of Pox in both groups @1mos. along with a 33% LS mean reduction in Pox from baseline @6mos. in group A & 42% in group B
- Oxlumo is an RNAi therapeutic targeting HAO1 leading to the depletion of GO enzyme & inhibition of oxalate production. Additionally, Oxlumo received approval from the US FDA (Nov’20) for the treatment of PH1 to lower UOx levels in pediatric/adult patients & from the EMA for the same indication in all age groups
Ref: Businesswire | Image: Alnylam
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