On Friday, March 7, the Food and Drug Administration announced the approval of Idelvion, a hemophilia B treatment developed by CSL Behring.
Using recombinant DNA technology is the key for the new product developed by CSL as its called Coagulation Factor IX, albumin fusion protein.
The technology used in the creation of the treatments links the blood accumulation protein Factor IX with albumin protein. The newly developed drug is indicated as a routine prophylactic treatment in order to prevent bleeding episodes occasioned by the hemophilia B disease, according to researchers from CSL Behring.
“Idelvion is produced by recombinant DNA technology linking Factor IX to albumin, a protein found in blood, which accounts for the product lasting longer when given intravenously,” said the U.S. Food and Drug Administration in a press release.
The disease consists of a congenital bleeding disorder where patients have shown a deficient recombinant Factor IX. Scientists have long waited for a solution for this disease as it causes patients to endure horrible bleeding, particularly in the joints.
Now, Idelvion contains a lasting albumin fusion protein that links recombinant coagulation Factor IX with recombinant albumin.
Idelvion shows its worth
The disease’s symptoms include prolonged bleeding into the joints, muscles, and internal organs and are mostly diagnosed in men, according to the press release from the FDA.
Idelvion’s objective is to efficiently prevent bleeding from happening and reduce the amount of episodes experienced by patients suffering the disorder.
In order to prove the medication’s accuracy on targeting the Factor IX and replacing it with the albumin fusion protein, two multicenter studies evaluated significant data.
The study was comprised of a total 90 adult and pediatric patients with the blood disorder in order to test the Hemophilia B therapy developed by CSL Behring.
Considering the study involved patients between 1 and 61 years of age, Idelvion was proven effective as a preventive measure for prolonged bleedings resulted by the blood disorder, said the press release by the FDA. Resulting in quite a success, the newly developed treatment for Hemophilia B showed no safety concerns according to the study’s data.
Source: FDA