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Grifols' Gamastan formulation gets FDA approval for HAV, measles

Grifols, a leading global producer of plasma-derived medicines, has received the green light from the Food and Drug Administration for a new formulation of its Gamastan immune globulin (human) for hepatitis A virus (HAV) and measles postexposure prophylaxis.

Gamastan, which is available in 10 mL and 2 mL vials, is manufactured using a sophisticated caprylate chromatography process, according to the highest quality and safety standards, and includes labeling for capacity to remove prions, the company said.

Gamastan is the only immune globulin product on the U.S. market approved for immediate protection against HAV and measles. The FDA approval is an important research and development milestone for Grifols as a global leader in postexposure prophylaxis — the treatment of a person after exposure to a virus — and immune globulin products for patients, according to the company.

"Vaccination, while a valuable option for hepatitis A and measles postexposure prophylaxis, may take several weeks to take effect as your immune system works to build the antibodies it needs to fight these viruses," MidState Medical Center infectious disease specialist Stephen Scholand said. "Immune globulins such as Gamastan have been a valuable treatment option for many decades because they offer immediate and rapid protection with antibodies that fight infection."

The Centers for Disease Control and Prevention states that for persons age 40 years old and older, an immune globulin is preferred for HAV postexposure prophylaxis. The CDC also recommends that immune globulin should be used for children aged less than 12 months, immunocompromised persons, persons with chronic liver disease and persons who are allergic to the vaccine or a vaccine component. When administered within two weeks after exposure to HAV, immune globulin is 80% to 90% effective in preventing hepatitis A infection, according to the CDC.

Gamastan also is approved for rubella and varicella postexposure prophylaxis.

"As a company driven by innovation, we strive to provide the highest-quality products possible to our patients" Grifols North America sales and commercial operations president Bill Zabel said in a statement. "This advancement in the Gamastan formulation marks an important milestone in Grifols' ongoing R&D efforts, and we are confident that it will continue to be an important treatment option for healthcare providers."
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