WASHINGTON (dpa-AFX) - Alnylam Pharmaceuticals, Inc. (ALNY) said the European Commission has granted marketing authorization for OXLUMO (lumasiran), an RNAi therapeutic, for the treatment of primary hyperoxaluria type 1 in all age groups. The approval is based on efficacy and safety findings from both the ILLUMINATE-A and ILLUMINATE-B Phase 3 studies of lumasiran.
Alnylam Pharma noted that the company has filed a New Drug Application with the U.S. FDA. The FDA has granted a Priority Review for the NDA and has set an action date of December 3, 2020.
Copyright RTT News/dpa-AFX
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