The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical company, for its JAK1/JAK2/ACVR1 inhibitor Ojjaara (momelotinib). The drug is indicated for anemic adults with intermediate or high-risk myelofibrosis, a blood cancer affecting approximately 25,000 people in the United States. This first-in-class drug is now the sole product approved in the US for both newly diagnosed and previously treated myelofibrosis patients, addressing anemia, constitutional symptoms, and splenomegaly.
Phase III Results Support Approval
The FDA’s decision is supported by Phase III clinical trial results that showed significant improvements in transfusion independence rates and a substantial reduction in spleen volume. These positive data were submitted for review in Japan last week, indicating the global significance of Ojjaara’s efficacy.
Ojjaara’s Triple Inhibitory Mechanism
Ojjaara’s unique triple inhibitory action targets JAK1 and JAK2 to alleviate constitutional symptoms and splenomegaly, and ACVR1 to reduce circulating hepcidin, a key contributor to anemia in myelofibrosis patients. This innovative approach offers a new standard of care for individuals living with this serious blood disorder.-Fineline Info & Tech
