Posted by Michael Wonder on 06 Oct 2018
FDA approves Revcovi, a new enzyme replacement therapy developed by Leadiant Biosciences, for the treatment of ADA-SCID in paediatric and adult patients
5 October 2018 - Leadiant Biosciences today announced that the FDA has granted approval to Revcovi (elapegademase-lvlr) injection in the U.S.
Revcovi is a new enzyme replacement therapy (ERT) for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in paediatric and adult patients. Revcovi is a PEGylated recombinant adenosine deaminase (rADA) enzyme developed by Leadiant Biosciences to treat ADA-SCID. The product of recombinant technology, Revcovi eliminates the need to source the enzyme from animals and works by supplementing levels of an essential enzyme called adenosine deaminase (ADA).
The approval is based on results from two multicenter, open-label clinical trials which demonstrate that Revcovi increases ADA activity, reduces concentrations of toxic metabolites that are the hallmark of ADA-SCID and improves total lymphocyte counts.
