YM gets orphan drug status for JAK1/2 drug

The FDA has granted orphan drug status to YM BioSciences’ (TSX:YM; AMEX:YMI) JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, in which a patient’s bone marrow is replaced by scar tissue, and for which treatment options are limited or unsatisfactory.

The designation provides YM with seven years of U.S. marketing exclusivity, tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and a waiver of PDUFA filing fees.

“CYT387 is a potent, oral JAK1/2 inhibitor that has been demonstrating very favourable biological activity data in our ongoing Phase 1/2 trial in myelofibrosis and the granting of orphan drug designation is a key regulatory milestone for our CYT387 clinical development program,” COO Dr. Nick Glover said in a statement.