EC grants approval for GSK’s Omjjara for treatment of myelofibrosis patients with anaemia

In a landmark decision, the European Commission has approved GSK plc’s Omjjara (momelotinib), introducing a revolutionary treatment for adult myelofibrosis patients suffering from moderate to severe anaemia. This authorization positions Omjjara as the first medicine in the EU specifically targeting disease-related splenomegaly (enlarged spleen) or symptoms in this patient demographic, whether newly diagnosed or previously treated with the standard of care, including ruxolitinib.

Nina Mojas, Senior Vice President, Oncology Global Product Strategy at GSK, expressed the significance of this approval, noting the profound impact myelofibrosis has on patients’ lives. Symptoms such as spleen enlargement, fatigue, night sweats, and bone pain can be debilitating, and until now, no treatments were specifically indicated for patients also contending with anaemia. Omjjara’s entry into the EU market not only fills this gap but also brings a novel mechanism of action to the forefront of myelofibrosis care.

The need for such a treatment is critical, with myelofibrosis affecting approximately 1 in 10,000 individuals in the EU. A staggering 40% of patients exhibit moderate to severe anaemia at diagnosis, a condition that almost invariably develops in nearly all patients as the disease progresses. This anaemia necessitates additional supportive care, including transfusions, and often leads to discontinuation of treatment due to its severity. The prognosis for transfusion-dependent patients is notably poor, highlighting the urgent need for effective treatment options.

Francesca Palandri, MD, PhD, from IRCCS S. Orsola-Malpighi, Bologna University Hospital, Italy, underscored the authorization’s importance, stating it represents a meaningful advancement for myelofibrosis patients, especially those with moderate to severe anaemia. The availability of Omjjara as a single therapy addressing key manifestations of myelofibrosis is a significant step forward.

The European Commission’s approval is based on the results from the MOMENTUM pivotal phase III trial and a subpopulation of adult patients with moderate to severe anaemia from the SIMPLIFY-1 phase III trial. These studies demonstrated momelotinib’s efficacy in treating and reducing key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population, and in comparison to ruxolitinib in JAK inhibitor-naïve patients.

Omjjara’s mechanism of action is distinguished by its ability to inhibit three key signaling pathways: JAK1, JAK2, and activin A receptor type 1 (ACVR1). This triple-action approach not only addresses constitutional symptoms and splenomegaly but also contributes to the management of anaemia-related issues by reducing circulating hepcidin levels.

With the EU’s authorization of Omjjara, GSK has established a new benchmark in the treatment of myelofibrosis, offering hope and a promising new option for patients across the EU facing the dual challenges of myelofibrosis and moderate to severe anaemia.

The European Commission’s authorization of GSK’s Omjjara marks a pivotal moment in the treatment of myelofibrosis in the EU. Addressing the significant unmet need in the management of disease-related symptoms and anaemia, Omjjara provides a beacon of hope for patients and healthcare providers alike. Its innovative mechanism and the comprehensive research supporting its approval exemplify the significant strides being made in understanding and treating complex hematological conditions. As we move forward, Omjjara’s role in enhancing the quality of life for myelofibrosis patients will undoubtedly be a focal point of interest and study within the medical community.