Orphan drug designation for SB1518 will entitle SBIO to tax credits on clinical research after designation and seven years of marketing exclusivity. Other potential benefits include regulatory fee waivers, grants for clinical research and protocol assistance.
The FDA accepted SBIO’s application upon review of preclinical data which demonstrated excellent anti-proliferative and anti-tumor activity, combined with very good tolerability of the JAK2 inhibitor.
Jan-Anders Karlsson, CEO of S*BIO, said: “There is a great need for effective treatment of myeloproliferative disorders caused by aberrant JAK2 signaling and SB1518 could potentially address this unmet medical need. The designation will allow us to optimize our development and regulatory strategy for SB1518.”