CSL Behring, King of Prussia, said the Food and Drug Administration has approved its new intravenous treatment, Idelvion, for treating patients with Hemophilia B.
The drug is a genetically-engineered albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin to treat Hemophilia B, a rare disease that affects 1 in 25,000 male babies. The treatment, which can be self-administered by patients, will be the first on the market with up to 14-day dosing, the company said. Plasma products for Hemophilia B must be infused every two to three days.
CSL Behring, which employs more than 500 at its King of Prussia headquarters, makes products to treat bleeding disorders, such as hemophilia and Von Willebrand disease, and immune deficiency diseases. The company, a unit of Australia's CSL Ltd., said Idelvion will be available by prescription from physicians later this month.