CANGENE'S VARICELLA IMMUNE VACCINE GRANTED ORPHAN DRUG STATUS

Cangene announced that its Varicella zoster immune globulin, VariZIG, has received orphan drug designation from the FDA for passive immunization of exposed, susceptible individuals who are at risk of complications from varicella. 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.

A vaccine can be granted orphan drug designation if the disease or condition it is intended to treat affects fewer than 200,000 people per year in the U.S.

VariZIG is a purified antibody preparation (hyperimmune) specific for Varicella zoster virus, which causes chickenpox and shingles. According to the company, the following types of patients are at-risk for serious infection if exposed to the virus: immune-compromised pediatric or adult patients, infants less than one year old, preterm infants, pregnant women and newborns whose mothers had a Varicella zoster infection within five days before or two days after delivery.