A new treatment for adults with Haemophilia B has been given FDA approval.
Hemgenix, the first gene therapy for the genetic bleeding disorder, got the go-ahead in late November, providing new hope for sufferers.
Treatment with Hemgenix is given in a single dose. The product contains a viral vector carrying a gene for clotting Factor IX — a protein needed to produce blood clots to prevent bleeding.
The FDA granted approval of the drug to CSL Behring LLC. The application received Orphan, Priority Review and Breakthrough Therapy designations.
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