Grifols, a global biotherapeutics company with major operations in North Carolina, has received approval from the U.S. Food and Drug Administration for a new formulation of GamaSTAN, its medicine for treating patients who’ve been exposed to the hepatitis A or measles viruses.
GamaSTAN is the only immune globulin product on the U.S. market approved for post- exposure protection against the two viruses. It is now available to healthcare providers across the country, the company said in a news release.
“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,” said Bill Zabel, president of the company’s North America sales and commercial operations.
The product’s approval and roll-out come amid a national resurgence of hepatitis A, a contagious liver infection, and measles, a contagious infection in young children that had been nearly eradicated through vaccinations.
“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,” said Stephen Scholand, M.D., an infectious disease specialist at MidState Medical Center in Meriden, Conn.
When administered within two weeks after exposure to the hepatitis A virus, immune globulin is 80 to 90 percent effective in preventing infection, according to the U.S. Centers for Disease Control.
In contrast, vaccinations – while still a valuable option – may not take effect for several weeks because the immune system needs time to produce antibodies against the viruses, Scholand said.
The CDC recommends immune globulin treatment after exposure to the hepatitis A virus in people who are immunocompromised, under 1 year old or over 40 years old, or who have cancer, chronic liver disease or kidney disease.
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