Mononine Soon Will No Longer Be Available to Treat Hemophilia B
CSL Behring, the therapy’s manufacturer, said the decision was based on the emergence of next-generation hemophilia B treatments now in greater use.
“Over time, patients have transitioned from older therapies to newer, next generation treatment options, and very few patients currently remain on MONONINE in the US,” CSL Behring wrote in a statement published on the Hemophilia Federation of America’s website. “Accordingly, we are discontinuing MONONINE.”
The medication is expected be available through mid-2021, based on current supply, giving patients time to move to another therapy.
“We understand this news may be challenging for the patients who remain on MONONINE,” the company added, encouraging those using Mononine “to talk with their Healthcare Professional soon to discuss alternate treatment options.”
Questions from patients and healthcare professionals can be directed to the company’s medical information center at 1-800-504-5434, Monday–Friday 9 a.m. to 5 p.m. ET.
Mononine is a plasma-derived clotting factor concentrate, one of the major classes of approved hemophilia B treatments. Replacement therapy involves using human plasma (the cell-free liquid part of blood) to replenish factor IX, the blood coagulation protein missing or defective in people with hemophilia B.
Mononine became the first highly purified factor IX approved by the U.S. Food and Drug Administration (FDA) in 1992. It is administered by intravenous infusion (directly into the bloodstream).
More recent options for hemophilia B treatment include AlphaNine SD, also a plasma-derived factor therapy to improve clotting and prevent or lessen excessive or uncontrolled bleeding. This intravenous injection treatment, marketed by Grifols, was approved by the FDA in 1996.
Rixubis, a replacement therapy approved by the FDA in 2013 and marketed by Takeda, is a recombinant factor IX product, which means that it is engineered to be similar to the body’s own clotting protein. In turn, Alprolix — Sanofi Genzyme‘s recombinant therapy for hemophilia B — is an extended half-life medication, as it has been designed to remain in the body longer and requires less frequent administration.
In people with severe hemophilia B, spontaneous bleeds may occur in the absence of injury, surgery, or other obvious cause. They may require regular, prophylactic therapy of factor IX to prevent bleeding.