HyperRAB, rabies immune globulin, receives FDA approval

Grifols, a leading global producer of plasma-derived medicines and provider of a variety of postexposure prophylaxis and immune globulin products for patients, has received approval from the U.S. Food & Drug Administration (FDA) for a new higher potency formulation of its HyperRAB® rabies immune globulin [human] for rabies postexposure prophylaxis (treatment of a person immediately after exposure to the rabies virus).

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, and for patients, the potential for fewer injections by significantly reducing the volume of medication administered in each dose.

“This is the first advancement in administration of human rabies immune globulin (HRIG) treatment in over 40 years,” said Dr. Charles Rupprecht, expert technical advisor on rabies for the PAHO/WHO, and former chief of the rabies program at the Centers for Disease Control and Prevention (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.”

The most common adverse reactions during clinical trials were injection-site pain and headache.

Approximately 60,000 people in the U.S. each year are treated with postexposure prophylaxis following exposure to an animal that is known, or thought, to have rabies. For patients who have not been vaccinated before, the Advisory Committee on Immunization Practices (ACIP) and 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.

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HyperRAB will now be available to U.S. patients in two sizes (1 mL/300 IU and 5 mL/1500 IU). This new formulation is manufactured using a sophisticated caprylate chromatography process, which significantly reduces procoagulant activity and product impurities such as IgG aggregates. This product is manufactured according to the highest quality and safety standards and includes labeling for prion removal. Grifols plans to expand its vial size offerings in the coming months.

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