12 February 2018 - - Barcelona, Spain-based global healthcare company Grifols (MCE: GRF, GRF.P, and NASDAQ: GRFS) has received approval from the US Food and Drug Administration for a new higher potency formulation of its HyperRAB rabies immune globulin [human] for rabies postexposure prophylaxis, the company said.
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 the potential for fewer injections.
The most common adverse reactions during clinical trials were injection-site pain and headache.
HyperRAB will now be available to US patients in two sizes (1 mL/300 IU and 5 mL/1500 IU).
This new formulation is manufactured using a 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.
Grifols is producer of plasma-derived medicines and provider of a variety of postexposure prophylaxis and immune globulin products for patients.
Its three main divisions--bioscience, diagnostic, and hospital--develop, produce, and market innovative products and services that are available in more than 100 countries. The company has approximately 18,000 employees in 30 countries.