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.

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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.

RTTNews | Nov 19, 2020 07:14AM EST

07:13 Thursday, November 19, 2020 (RTTNews.com) - 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.

Read the original article on RTTNews ( https://www.rttnews.com/3147352/alnylam-gains-approval-for-oxlumo-in-european-union-for-treatment-of-primary-hyperoxaluria-type-1.aspx)

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