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FDA approves Leadiant therapy for ADA-SCID

October 8, 2018 7:56 PM UTC

Leadiant Biosciences Inc. said FDA approved Revcovi elapegademase-lvlr (EZN-2279) to treat pediatric and adult patients with adenosine deaminase severe combined immunodeficiency.

Approval of the pegylated recombinant adenosine deaminase enzyme replacement therapy is based on two Phase III trials in the U.S. and Japan in which Revcovi increased plasma or serum ADA activity and lymphocyte counts and led to metabolite detoxification in 10 patients with ADA-SCID undergoing treatment with Leadiant's marketed enzyme replacement therapy Adagen pegademase...

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