Ojjaara FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 18, 2023.
FDA Approved: Yes (First approved September 15, 2023)
Brand name: Ojjaara
Generic name: momelotinib
Dosage form: Tablets
Company: GlaxoSmithKline
Treatment for: Myelofibrosis
Ojjaara (momelotinib) is a JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor for the treatment of myelofibrosis patients with anemia.
- Ojjaara is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [postpolycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.
- Myelofibrosis is a rare cancer of the bone marrow that progressively impairs red blood cell production. It results from dysregulated JAK-signal transducer and activator of transcription protein signalling and is characterised by constitutional symptoms, splenomegaly, and progressive anemia.
- Ojjaara contains momelotinib, which has inhibitory ability along three key signaling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1). Ojjaara works to treat myelofibrosis through inhibition of JAK1 and JAK2, which may improve constitutional symptoms and splenomegaly, and inhibition of ACVR1 which leads to a decrease in circulating hepcidin, resulting in increased red blood cell production. Levels of hepcidin are elevated in myelofibrosis and contribute to anemia.
- Ojjaara tablets are administered orally once daily with or without food.
- Warnings and precautions associated with Ojjaara include risk of infections, thrombocytopenia and neutropenia, hepatotoxicity, major adverse cardiovascular events (MACE), thrombosis, and malignancies.
- Common adverse reactions include thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.
Development timeline for Ojjaara
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
