Escend Pharmaceuticals, Inc. announced that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for its lead product candidate, ES-3000, for the treatment of acute myeloid leukemia (AML). The FDA previously granted ES-3000 orphan designation for the treatment of chronic myeloid leukemia (CML).
"This accomplishment validates the potential significance ES-3000 can have in shifting the AML treatment paradigm," said Saira Bates, Co-founder & CEO of Escend. "The treatment of patients with AML is complicated by relapse and refractory disease which is often attributed to the resistance of leukemic stem cells to standard therapeutics. ES-3000 will be used in conjunction with standard agents to target leukemic stem cells for more durable remissions."
The FDA orphan drug designation provides 7 years of marketing exclusivity and certain incentives, including federal grants, tax credits, and waived FDA fees. Successive drug approvals for ES-3000 in the treatment of CML and AML give Escend the possibility of up to 14 years of drug exclusivity.