FDA Approves VARIZIG for Treatment of Varicella Zoster Virus in High-Risk Patients

VARIZIG, a hyperimmune globulin indicated for post-exposure prophylaxis of varicella zoster virus (VZV) in high-risk patients, has been approved by the U.S. Food and Drug Administration (FDA). Manufactured by Cangene Corp. in Winnipeg, Manitoba, Canada, VARIZIG is the only FDA-approved hyperimmune globulin for VZV after exposure available in the United States. An earlier FDA-licensed VZIG was removed from the U.S. market by the manufacturer in 2006, and VARIZIG has been available only under an investigational expanded access protocol during the licensing process. It was designated as an orphan drug by the FDA and received a priority review.¹

VZV causes chickenpox in children and shingles in adults. VARIZIG is an antibody preparation manufactured from plasma of healthy donors with high anti-VZV antibody levels. It is administered in two or more injections,³ depending on the weight of the recipient, and it is approved for immunocompromised children and adults, newborns, pregnant women, premature infants, children younger than 1 year, and adults with no immunity to VZV.^1,3

According to the Centers for Disease Control and Prevention, immune-compromised individuals who contract chickenpox are at risk of developing severe complications that can sometimes be fatal. Pregnant women who contract the virus are at increased risk for developing pneumonia, and becoming infected early in pregnancy can put their newborns at risk for low birth weight and birth defects, including limb abnormalities.³ When an expectant mother develops chickenpox in the week before birth, the virus can result in a life-threatening infection in a newborn.2 According to the drug’s manufacturer, VARIZIG is indicated for use in any of these instances.

“This approval fills an unmet need by providing a treatment to lower the risk of severe, potentially fatal varicella infections in vulnerable patients,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release regarding the drug’s approval.¹

In studies, VARIZIG was shown to be comparable to VZIG and was as effective as VZIG in preventing severe infection during pregnancy. Data on VARIZIG collected from individuals treated under the expanded access protocol showed a low rate of severe VZV infection in susceptible individuals compared with the rate in untreated individuals. The studies also showed that VARIZIG is safe for its intended use, with the most common side effects being pain at the injection site and headache.¹

Varicella vaccination is not recommended for children with congenital or acquired T-lymphocyte immunodeficiency, including children receiving long-term immunosuppressive therapy, because of risk for complications from live vaccine virus infection. These patients are at high risk for severe or fatal varicella and depend on indirect protection through high levels of varicella immunity among the general population, and especially among their close household contacts. In these patients, if exposure to VZV occurs, post-exposure prophylaxis with VARIZIG is recommended. VARIZIG should be administered as soon as possible after exposure, ideally within 96 hours for greatest effectiveness.^2,3

VARIZIG is now exclusively distributed by FFF Enterprises (www.fffenterprises.com), a distributor of biopharmaceuticals, critical-care plasma products and vaccines. FFF also partnered with Cangene as sole distributor of VARIZIG during its investigational new drug expanded access protocol and clinical trial phases.

“We are very proud to continue as the exclusive distributor for this unique product,” said Patrick M. Schmidt, chief executive officer, FFF Enterprises. “VARIZIG offers a specific protection to those most vulnerable to the varicella zoster virus. Having it readily available in our product portfolio supports our mission of ‘Helping Healthcare Care.’”