fda-approval-letter
PHARMACY

Leadiant Bioscience gets FDA green light for Revcovi

BY Sandra Levy

Leadiant Bioscience has received the Food and Drug Administration’s blessing for Revcovi (elapegademase-lvlr) injection.

Revcovi is a new enzyme replacement therapy for the treatment of adenosine deaminase severe combined immune deficiency, or ADA-SCID, in pediatric and adult patients.

“We are gratified by the FDA’s timely recognition of Revcovi as an effective and safe treatment for ADA-SCID, which, in addition to being ultrarare, is one of the most devastating genetic disorders,” Leadiant Biosciences CEO Michael Minarich said in a statement. “We extend our deepest gratitude to the patients who participated in the clinical trials and their families and caregivers who supported them. We also appreciate the hard work of the investigators, clinicians and study staff to bring this therapy to patients in need. We look forward to continuing to work together to serve the ADA-SCID community.”

Revcovi is a PEGylated recombinant adenosine deaminase enzyme used 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, or ADA.

ADA-SCID is an ultrarare, inherited genetic disorder, caused by a deficiency in the ADA enzyme that is fatal if left untreated. Patients affected by ADA-SCID have compromised immune systems that leave them unprotected from infection-producing bacteria, viruses and fungi. ADA-SCID primarily affects infants and young children. The disease is typically diagnosed within the first few months of life. Undiagnosed babies with ADA-SCID usually die before they reach the age of two due to infections. SCID newborn screening in most states has allowed detection of ADA-SCID in newborns and has led to early initiation of ADA enzyme therapy and improved outcomes.

The FDA granted this application Fast Track and Priority Review. Revcovi also received Orphan Drug designation.

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