Alnylam completes rolling submission of NDA to the FDA and submits MAA to the European Medicines Agency for lumasiran for the treatment of primary hyperoxaluria Type 1.
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Alnylam Pharmaceuticals, Inc. has announced that pivotal trial results from the ILLUMINATE-A Phase III study of lumasiran, an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – for the treatment of primary hyperoxaluria type 1 (PH1), were published online in The New England Journal of Medicine (NEJM).
Alnylam Pharmaceuticals, Inc.has announced that the FDA approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. PH1 is an ultra-rare genetic disease characterized by oxalate overproduction.
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced that the European Commission (EC) has granted marketing authorization for Oxlumo (lumasiran), an RNAi therapeutic, for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.