Friday, September 29, 2023

FDA approves GSK’s Ojjaara for myelofibrosis

The British pharmaceutical company GSK has announced that the US Food and Drug Administration (FDA, the English acronym) has conducted tests Ojjara (Momelotinib) to treat myelofibrosis, a type of bone marrow cancer, in adults with anemia. With this approval it becomes first available drug for this type of newly diagnosed and already treated patients.

“The vast majority of patients with myelofibrosis They end up developing anemia, causing them to interrupt treatment and require transfusions. Given this great unmet need, we are proud to add Ojaara to our oncology portfolio and address a medical necessity important in the community. We look forward to helping improve outcomes in this difficult-to-treat blood cancer,” said Nina Mojas, senior vice president of global oncology product strategy at GSK.

Myelofibrosis affects approximately 25,000 patients in the United States and causes anemia, thrombocytopenia, fatigue, night sweats, and bone pain, among other symptoms. Of the total number of diagnosed patients 40% Of these, they suffer from moderate or severe anemia, and it is estimated that almost all will develop it during the course of the disease.

“Given this significant unmet need, we are proud to add Ojjaara to our oncology portfolio and address an important medical need in the community.”

“With momelotinib we have the potential to establish one new standard of care for patients with myelofibrosis and anemia. “Treating the key manifestations of myelofibrosis, including anemia, constitutional symptoms and splenomegaly, makes a significant difference in the treatment regimen for these patients, who have limited options to address these aspects of the disease,” he says. Ruben A. Mesa President and deputy director of Atrium Health Levine Cancer Center and Atrium Health Wake Forest Baptist Comprehensive Cancer Center.

FDA approval is supported by the Study of the fundamental MOMENT and that Phase III study SIMPLIFY-1. MOMENTUM was designed to evaluate the safety and efficacy of momelotinib compared to danazol for the treatment and reduction of manifestations in an anemic population.

“We are pleased that momelotinib is coming to the clinic, providing patients and their physicians with another option for treating myelofibrosis. Any new treatment that takes steps toward solving the mysteries of this complex and chronic blood cancer represents a… great progress for the field“, he emphasizes Kapila Viges Managing Director of the MPN Research Foundation.

Nation World News Desk
Nation World News Desk
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