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FDA approves GSK’s Ojjaara for treating myelofibrosis patients with anaemia

2023-09-18

上市批准临床结果临床3期并购加速审批

Phalguni Deswal

@Phalguni_GD

Ojjaara was included in GSK’s portfolio after the acquisition of Sierra in 2022. Image Credit: William Barton / Shutterstock.

The US Food and Drug Administration (FDA) has approved GSK’s Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis patients with anaemia.

Ojjaaraermediate or highGSKsk myelofibrosis patients include individuals with primary or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia). In June, the FDA pushed the Prescription Drug User Fee Act (PDUFA) target action date for the drug to September without disclosing any reason for the extension.

RecommeFood and Drug Administration (FDA)GSK high-risk myelofibrosis anaemia

ReportsLOA and PTSR Model - Ramyelofibrosissimilar in Diabetic Macular Edema Gprimary or secondary myelofibrosis polycythaemia vera post-essential thrombocythemia FDA

ReportsLOA and PTSR Model - Siremadlin Succinate in Myelofibrosis GlobalData

View allCompanies IntelligenceNovartis AGGSK plcIncyte CorpSierra Oncology IncLancetView all

Ojjaara is a once-daily JanuRanibizumabAK)1/JAK2 and aDiabetic Macular Edema 1 (ACVR1) inhibitor initially developed by Sierra Oncology. Ojjaara was included in GSK’s portfolio after the acquisition of Sierra in 2022.

Myelofibrosis is a rare blood cancer that is characterised by the build-up of scar tissue (fibrosis) in the bone marrow. Due to marrow fibrosis, the common symptom of the disease is low blood counts including red blood cells (anaemia).

According to the National OrSiremadlin SuccinateDiseMyelofibrosis myelofibrosis affects 1.5 people per every 100,000 individuals in the US. The commonly prescribed FDA-approved treatment for myelofibrosis includes Novartis and Incyte’s Jakafi (ruxolitinib). Jakafi generated $1.2bn in global sales in H1 2023, as per Incyte’s Q2 financial report.

GlobalData forecasts Ojjaara to have modest sales of $499m in 2029 compared to Jakafi’s sales of $3.1bn in the same period.

Ojjaaraata is the parent company of Pharmaceutical Technology.Sierra Oncology Ojjaara GSK

Myelofibrosisis based onblood cancerse III studies, Momentum (NCT04173494) and Simplify-1 (fibrosis838) which compared Ojjaara to other myelofibrosis therapies, danazol and Jakafi, respectively.anaemia

The results from the Momentum trial were published in the primary myelofibrosis0% or more reduction in the total symptom score with Ojjaara compared to danazol.myelofibrosis Novartis Incyte Jakafi Incyte

Data from the subgrouOjjaaratients from the Simplify-1 trial was also part of tJakafiroval and showed that Ojjaara reduced the spleen volume response by 35% or more.

The commonly observed adverse eventsPharmaceutical Technologya (low platelet count), haemorrhage, bacterial infection, fatigue, dizziness, diarrhoea, and nausea.

Ojjaara is also being evaluated in other conditions such as non-small cell lung cancer, polycythaemia vera, and pancreaOjjaaratal adenocmyelofibrosis danazol Jakafi

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