ProNAi Therapeutics, Inc. announced that its oncology drug candidate PNT2258 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell lymphoma (DLBCL).
This is the second orphan drug designation obtained by ProNAi for PNT2258 for the treatment of DLBCL, following a similar grant by the European Commission in August 2015.
ProNAi has also previously received European Commission Orphan Drug Designation for PNT2258 for the treatment of patients with DLBCL. In addition to a 10-year period of market exclusivity in the EU following marketing authorization, receiving orphan drug designation provides other incentives for companies, including scientific advice and protocol assistance during the product's development phase.
