A biopharmaceutical company's drug has been approved by the US Food and Drug Administration for treating people with hemophilia B.
CSL Behring has developed the drug 'Idelvion' through the recombinant DNA technology. Hemophilia B is a congenital disorder that is characterized by the recurring episodes of bleeding due to deficient recombinant Factor IX.
‘FDA has approved Idelvion, a coagulation Factor IX (recombinant), albumin fusion protein for children and adults with hemophilia B.’
Idelvion contains a lasting albumin fusion protein that links recombinant coagulation Factor IX with recombinant albumin. The drug has been tested in 90 adult and pediatric patients with the blood disorder. It proved effective for a 7-day and 14-day period by preventing blood loss.
"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.
The results showed that 94 percent of bleeds were controlled with one infusion while 99 percent were controlled with one or two infusions. Therefore, patients can inject the drug only once in 15 days or fortnight than injecting it twice or thrice a week. The drug is reported to hit the US markets by this month end while its is already available in Canada.
"Idelvion is the first product from our innovative recombinant factor development program to receive FDA approval. We are proud to add this therapy to our growing portfolio of bleeding disorder products, and are particularly excited abut the positive impact treatment with Idelvion can have on the well-being with patients with hemophilia B," said Andrew Cuthbertson, CSL chief scientific officer.