FDA Approves Momelotinib in Patients with Myelofibrosis Plus Anemia

Momelotinib (Ojjaara) has been approved by the US Food and Drug Administration (FDA) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia.

The FDA approval is for use in myelofibrosis patients with anemia regardless of prior myelofibrosis therapy. Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease, and over 30% will discontinue treatment due to anemia, according to GSK, the manufacturer of the drug.

The FDA approval of momelotinib is supported by data from the pivotal MOMENTUM study and a subpopulation of adult patients with anemia from the SIMPLIFY-1 phase III trial.