Viracyte, a biopharmaceutical agency focused on developing immunotherapies for death causing infections, has recently announced that US Food and Drug Administration has granted Orphan Drug Designation to Viralym-C, the company’s leading T cell immunotherapy for the treatment of cytomegalovirus (CMV) in severely immune-compromised patients. On 10th January, 2017, the therapy has been awarded with FDA Fast Track designation.
FDA's Orphan Drug Designation program provides certain incentives for companies developing therapeutics to treat rare diseases or conditions, defined as those affecting less than 200,000 individuals in the U.S. A drug candidate and its sponsor must meet several key criteria in order to qualify for, and obtain, orphan drug status. Once a drug has received orphan drug designation, the developer qualifies for a range of benefits, including federal grants, tax credits, reduction in certain regulatory fees, and the potential for seven years of market exclusivity for the drug following FDA marketing approval.
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