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Alnylam makes case for lumasiran in infants ahead of FDA ruling  

Alnylam has shared data from a phase 3 trial of its near-approval kidney disease drug lumasiran in children as young as three months. The RNAi therapy drove a 72% reduction in urinary oxalate from baseline, boosting Alnylam’s hopes of using the drug in a broad patient population.

Earlier this year, Alnylam filed for FDA approval of lumasiran on the strength of data linking it to a 65% drop in urinary oxalate in people with primary hyperoxaluria type 1 (PH1) aged six years and up. Last month, Alnylam followed up with news that lumasiran drove a “clinically significant” decline in urinary oxalate in children aged three to 72 months but held off on publishing the data.

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