“Today’s approval provides a new treatment option for patients with hemophilia B and represents important progress in the development of innovative therapies.”
The Food and Drug Administration cleared Hemgenix, an IV treatment for adults with hemophilia B, the less common form of the genetic disorder which primarily affects men. Currently, patients receive frequent, expensive IVs of a protein that helps blood clot and prevent bleeding.
Like most medicines in the U.S., most of the cost of the new treatment will be paid by insurers — not patients — including private plans and government programs. “Today’s approval provides a new treatment option for patients with hemophilia B and represents important progress in the development of innovative therapies,” said the FDA’s Dr. Peter Marks.
Hemophilia almost always strikes males and is caused by mutations in the gene for a protein needed for blood clotting. Small cuts or bruises can be life-threatening, and many people need treatments once or more a week to prevent serious bleeding. Left untreated, the condition can cause bleeding that seeps into joints and internal organs, including the brain.Hemophilia B affects about 1 in 40,000 people and accounts for roughly 15% of those with the disease, according to the FDA.
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