Spring 2019 - Safety

FDA Approves Hepatitis A and Measles Exposure Drug

The U.S. Food and Drug Administration (FDA) has approved Grifols’ GamaSTAN to treat people exposed to measles and the hepatitis A viruses. GamaSTAN is the only immune globulin (IG) product available in the United States to protect against these viruses after exposure. “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,” said Stephen Scholand, MD, an infectious disease specialist at MidState Medical Center. “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 (CDC) recommends IG for hepatitis A virus (HAV) postexposure treatment for people over 40 years. In addition, CDC recommends IGs should be used for children age 12 months and younger, immunocompromised persons, persons with chronic liver disease and those who are allergic to the vaccine or a vaccine component. “When administered within two weeks after exposure to HAV, immune globulin is 80 percent to 90 percent effective in preventing hepatitis A infection,” said a CDC spokesperson.

GamaSTAN is also approved for rubella and varicella postexposure treatment. However, it is not indicated for routine prevention or treatment of viral hepatitis type B, rubella, poliomyelitis, mumps or varicella.

References

Jefferson RS. FDA Approves New Drug for Hepatitis A and Measles Exposure. Forbes, Sept. 12, 2018. Accessed at www.forbes.com/sites/robinseatonjefferson/2018/09/12/fda-approves-new-drug-forhepatitis-a-and-measles-exposure/#303358a3a410.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.