Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.SBIO has announced that the FDA has granted orphan drug designation to SB1518, its potent and orally-active JAK2 inhibitor for the treatment of myeloproliferative disorders.
Subscribe to our email newsletter
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.”