GSK plc has announced that Ojjaara (momelotinib) has received the green light from the US Food and Drug Administration (FDA) to treat adults with anemia suffering from intermediate or high-risk myelofibrosis, which includes primary myelofibrosis and secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia).
Ojjaara, a daily oral JAK1/JAK2 and ACVR1 inhibitor, stands out as the sole approved drug for anemic myelofibrosis patients, whether newly diagnosed or previously treated. It addresses major signs of the condition: anemia, constitutional symptoms, and an enlarged spleen (splenomegaly).
The FDA’s approval for momelotinib is backed by findings from the critical MOMENTUM trial and a subset of anemic adult participants in the SIMPLIFY-1 phase III examination. MOMENTUM aimed to compare the safety and effectiveness of momelotinib and danazol in treating significant symptoms of myelofibrosis among anemic, symptomatic individuals with prior experience with JAK inhibitors.
Nina Mojas, Senior Vice President of Oncology Global Product Strategy at GSK, noted that the majority of myelofibrosis patients eventually suffer from anemia, which results in the discontinuation of treatments and the need for transfusions. She emphasized the significant unmet medical need in the community and expressed GSK’s pride in adding Ojjaara to their oncology portfolio. Mojas also conveyed the company’s anticipation to enhance outcomes for this challenging blood cancer.
Source: Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia.
https://www.gsk.com/en-gb/media/press-releases/ojjaara-momelotinib-approved-in-the-us-as-the-first-and-only-treatment-indicated-for-myelofibrosis-patients-with-anaemia/#:~:text=GSK%20plc%20(LSE%2FNYSE%3A,essential%20thrombocythaemia)%2C%20in%20adults%20with
