Grifols USA , LLC issued the following announcement on Feb. 6.
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.
Grifols has been a trusted provider of rabies immune globulin for over 40 years. This new formulation is the latest version of Grifols' current rabies immune globulin, HyperRAB S/D, which is presently the number one prescribed rabies immune globulin in the United States.
"Since the launch of the first version of HyperRAB 40 years ago, nearly a million patients worldwide have received treatment with this product to decrease risks associated with rabies exposure," said Bill Zabel, President, Grifols North America Sales and Commercial Operations. "With HyperRAB now available in a 300 IU/mL strength, physicians can significantly reduce the volume of medication delivered in each dose, which is the single biggest challenge today. This new formulation increases the long-standing confidence physicians have in what Grifols' rabies immune globulin treatment can deliver to patients who need protection from a condition that is essentially 100 percent fatal."
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.
Original source can be found here.
Alerts Sign-up