Higher-Potency Rabies IG Vaccine Receives FDA Approval

Grifols’ HyperRAB (rabies immune globulin [human]) has been approved by the U.S. Food and Drug Administration (FDA) to treat rabies postexposure prophylaxis. The new formulation is twice the potency (300 IU/mL) of currently available rabies immune globulin options, offering a greater concentration of anti-rabies virus antibodies within each mL of volume, as well as the potential for fewer injections by significantly reducing the volume of medication administered in each dose. It is manufactured using a caprylate chromatography process, which reduces procoagulant activity and product impurities such as IgG aggregates.

Each year, approximately 60,000 people in the U.S. are treated with postexposure prophylaxis following exposure to an animal that is known or believed to have rabies. The Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention (CDC) recommend immediate prophylaxis following exposure to rabies, including a rabies immune globulin injection directly into the wound site to prevent the virus from entering the central nervous system, which eventually leads to death.

“This is the first advancement in administration of human rabies immune globulin treatment in over 40 years,” said Charles Rupprecht, VMD, MS, PhD, expert technical advisor on rabies for the Pan American Health Organization/World Health Organization, and former chief of the rabies program at CDC. “Because patients are required to be dosed by weight, the increased potency of this new formulation allows more rabies antibodies per mL to go directly into wounds in delicate areas such as the extremities or face. Administration in these areas has proven to be very uncomfortable for patients, especially children, and challenging for healthcare professionals in administration of the full dose.”