www.fdanews.com/articles/84600-tolerrx-receives-orphan-drug-designation-from-trx4
TOLERRX RECEIVES ORPHAN-DRUG DESIGNATION FROM TRX4
February 15, 2006
TolerRx has reported that its lead product, TRX4, has received orphan-drug designation by the FDA for the treatment of new-onset Type 1 diabetes mellitus. TolerRx is currently conducting a clinical study of TRX4 in the U.S. in subjects with Type 1 diabetes. Orphan-drug designation would entitle TolerRx to exclusive TRX4 marketing rights in the U.S. for seven years should TolerRx be the first company to receive marketing approval for this type of therapeutic drug product.