MHRA approves GSK’s Omjjara in Great Britain for splenomegaly treatment
Betsy Goodfellow | January 31, 2024 | News story | Medical Communications | GSK, MHRA, Omjjara, Oncology, myelofibrosis, splenomegaly
GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation to Omjjara (momelotinib) in Great Britain (GB).
The drug has been approved for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate-to-severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or who have previously been treated with ruxoltinib.
This approval follows data from the MOMENTUM phase 3 trial and a subpopulation of adult patients with moderate-to-severe anaemia from the SIMPLIFY-1 phase 3 trial.
Jack Harris, vice president of UK Oncology at GSK, commented: “At GSK, we are committed to driving innovation for those living with unmet needs. We welcome today’s decision. As the first JAK-inhibitor treatment licensed in Great Britain specifically indicated for adult myelofibrosis patients with moderate to severe anaemia, this milestone could have an impact on this patient population living with myelofibrosis across Great Britain. We look forward to working with all stakeholders to help allow eligible myelofibrosis patients to access this treatment on the NHS as soon as possible.”
Professor Claire Harrison, deputy chief medical officer, Research, Data and Analytics, at Guy’s and St Thomas’, added: “Myelofibrosis is a rare blood cancer with limited treatment options. The approval of Omjjara (momelotinib) is the culmination of many years of collaboration and participation by hundreds of patients in clinical trials. We are very grateful to those who took part as it has enabled this new option for treating myelofibrosis patients with moderate to severe anaemia.”
Betsy Goodfellow
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