YM BioSciences Announces Orphan Drug Designation for JAK1/JAK2 Inhibitor CYT387 in Europe
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YM BioSciences Inc. has announced that it has received positive opinions from the Committee for Orphan Medicinal Products of the European Commission to grant Orphan Medicinal Product Designation to its JAK1/JAK2 inhibitor, CYT387, for the treatment of primary myelofibrosis, post-polycythaemia vera myelofibrosis and post-essential thrombocythaemia myelofibrosis.
Myelofibrosis is a chronic debilitating unmet medical need in which a patient's bone marrow is replaced by scar tissue, and for which treatment options are limited or unsatisfactory.
"CYT387 has demonstrated early efficacy in improving the key aspects of myelofibrosis including anemia, splenomegaly and a range of debilitating symptoms," said Dr. Nick Glover, President and CEO of YM BioSciences.
Glover continued, "Having our JAK inhibitor designated as an orphan drug for the treatment of myelofibrosis in Europe, in addition to our previously obtained orphan designation in the US, will help ensure that we are able to advance this drug as efficiently as possible for these patient groups."
Orphan Medicinal Product Designation from the European Commission is granted to medicines intended for the treatment of life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in the EU.
Developers of medicines that have received orphan designation may receive fee reductions, protocol assistance, access to the centralized authorization procedure, as well as 10 years of marketing exclusivity once authorized.
The U.S. Food and Drug Administration (FDA) has previously granted Orphan Drug Designation to CYT387 for the treatment of myelofibrosis.