FDA Approves New Formulation of Rabies Immune Globulin for Post-Exposure Prophylaxis

The US Food and Drug Administration (FDA) has approved Grifols’ new, higher potency formulation of its HyperRAB rabies immune globulin for rabies post-exposure prophylaxis and immune globulin for patients.

The new formulation boasts double the potency (300 IU/mL) than other rabies immune globulin options that are currently available, according to the press release. As such, it offers a higher concentration of anti-rabies virus antibodies within each mL of volume, which could potentially translate into fewer injections needed for patients.

While human rabies cases are rare in the United States, 23 cases of human rabies have been reported in the past decade, ranging from 2008 to 2017, according to the Centers for Disease Control and Prevention (CDC).

Many advancements have been made when it comes to animal control, vaccination, and outreach efforts, but this is the first advancement in administration of human rabies immune globulin treatment in over 40 years, according to Dr. Charles Rupprecht, expert technical advisor on rabies for the Pan American Health Organization/World Health Organization, and former chief of the rabies program at the 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,” Dr. Rupprecht explained in the press release. “Administration in these areas has proven to be very uncomfortable for patients, especially children, and challenging for health care professionals in administration of the full dose.”

In the United States, about 60,000 individuals are treated with postexposure prophylaxis on an annual basis, after being exposed to a rabid animal. The CDC’s Advisory Committee on Immunization Practices recommends that patients who have not been vaccinated in the past receive immediate prophylaxis following a potential rabies exposure, “including a rabies immune globulin injection directly into the wound site to prevent the virus from entering the central nervous system,” which could have life-threatening implications.

“The new formulation is manufactured using a sophisticated caprylate chromatography process, which significantly reduces procoagulant activity and product impurities such as IgG aggregates,” according to the press release.

Now, HyperRAB will be available in the United States in 2 sizes: 1 mL/300 IU and 5 mL/1500 IU).