Leadiant Biosciences announced that the Food and Drug Administration (FDA) has approved Revcovi (elapegademase-lvlr) injection, a new enzyme replacement therapy (ERT) for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID).
ADA-SCID is an ultra-rare, inherited genetic disorder caused by an ADA enzyme deficiency, that if left untreated, can be fatal. The condition mainly affects infants and young children and is diagnosed within the first few months of life. Revcovi, a PEGylated recombinant adenosine deaminase, works by supplementing levels of the ADA enzyme, eliminating the need to source the enzyme from animals.
The FDA approval was supported by data from 2 multicenter, open-label clinical trials (Study 1 [N=6] and Study 2 [N=4]). The data showed treatment with Revcovi increased ADA activity, decreased concentrations of toxic metabolites, and improved total lymphocyte counts. Cough and vomiting were the most common adverse reactions associated with Revcovi therapy.
“Individuals with ADA-SCID are at an increased risk of severe and recurrent infections and often fail to thrive,” said Morna Dorsey, MD, MMSc, Professor of Pediatrics at the University of California, San Francisco. “By providing specific and direct replacement of the adenosine deaminase enzyme, Revcovi can reduce patients’ risk of potentially serious, life-threatening infections and their debilitating complications.”
Revcovi is expected to be available by the end of 2018 in single-dose vials containing 2.4mg/1.5mL (1.6mg/mL) sterile, preservative-free solution for intramuscular (IM) injection.
For more information call (888) 393-4584 or visit Revcovi.com.