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01/24/2019 - 02:08

FDA approves Revcovi ( elapegademase-lvlr )

Elapegademase-lvlr is a novel enzyme replacement therapy for the treatment of adenosine deaminase deficiency in severe combined immunodeficiency (ADA-SCID) in children and adults. (ADA-SCID is an ultra-rare and highly destructive hereditary disease. Patients affected by ADA-SCID have an impaired immune system that prevents patients from fighting bacterial, viral and fungal infections.)

Revcovi is a PEGylated recombinant adenosine deaminase (rADA) preparation developed for the treatment of ADA-SCID. As a genetically engineered recombinant, Revcovi eliminates the need to extract enzymes from animals, and the drug will become an alternative to Leadiant's current enzyme replacement therapy (ERT) Adagen (pegademase bovine). It is derived from cattle and was launched in 1990, providing ADA-SCID patients with the first treatment option in addition to bone marrow transplantation.
Revcovi's approval is based on the results of two multicenter, open-label clinical studies. These studies indicate that Revcovi increases ADA activity in ADA-SCID patients, reduces the toxic metabolite concentration of ADA-SCID markers, and increases the total number of lymphocytes.
Revcovi's approval is a big boost for Leadiant, who is currently facing fierce criticism from the public, accusing it of being overpriced for another rare disease drug. A Dutch non-profit organization has filed a lawsuit against Leadiant (formerly Sigma-tau), accusing it to increase the price of deoxycholic acid (CDCA) by a factor of 500.

ADA-SCID, also known as "bubble boy disease", is an ultra-rare and highly destructive hereditary disease caused by a deficiency in ADA enzyme that can be fatal if left untreated.

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

REVCOVI is a drug used to treat adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. REVCOVI replaces the missing ADA enzyme in patients with ADA-SCID.

ADA-SCID is a rare, inherited, genetic disorder caused by a deficiency in the adenosine deaminase (ADA) enzyme. Patients affected by ADA-SCID have compromised immune systems that leave them unprotected from infection. The condition can be life threatening if left untreated.

How is this drug used?

REVCOVI is injected into the muscle (an intramuscular injection) weekly.

The dose depends on the patient’s weight.

What are the benefits of this drug?

REVCOVI increases ADA enzyme activity.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

 The number of patients in the trial was small; therefore, differences in how well the drug worked among sex, race, and age subgroups could not be determined.

Source

URL: https://www.fda.gov/Drugs/InformationOnDrugs/ucm624818.htm

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