The types of patients who are at-risk for serious infection if exposed to the virus are immune compromised pediatric or adult patients, infants less than one year old, pre-term infants, pregnant women and newborns whose mothers had varicella zoster infection within five days before or two days after delivery.
This designation will give the drug seven years of market exclusivity after marketing approval is obtained. It also means certain regulatory filing fees will be waived.
“This designation is another step in our commitment to address the unmet medical need faced by susceptible individuals who are exposed to chickenpox. It builds on the expanded access investigational new drug protocol that was approved in January by the FDA,” said Dr John Langstaff, Cangene’s president and CEO.
VariZIG is a purified antibody preparation (hyperimmune) specific for varicella zoster virus, which causes chickenpox and shingles. The company has three FDA approved hyperimmunes that it manufactures using similar processes.