Novartis says it plans to file for approval of its myelofibrosis (MF) therapy candidate INC424 worldwide during 2011 on the back of positive data from a Phase III trial. The firm is developing the drug for non-U.S. markets under license from Incyte.
The pivotal Comfort-1 study showed treatment with INC424 led to significant reductions in spleen size in patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF). The secondary endpoint of symptomatic improvements measured by the modified Myelofibrosis Symptom Assessment Form Diary, was also met.
INC242 has been granted orphan drug status for MF by both FDA and the European Medicines Agency.