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
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