Novartis drug Jakavi® receives European Commission approval to treat myelofibrosis
Novartis today received approval from the European Commission for Jakavi® for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
Jakavi® (INC424, ruxolitinib), is a JAK 1 and JAK 2 inhibitor and received approval based on positive results from the most extensive myelofibrosis clinical trial program to date – the COMFORT (COntrolled MyeloFibrosis study with ORal JAK inhibitor Therapy) clinical trial program.
Myelofibrosis is a rare, life-threatening blood cancer associated with progressive, debilitating symptoms that can severely impact quality of life and shorten survival.
“The approval of Jakavi by the European Commission brings an urgently needed new treatment option with the potential to make a real difference in patients’ lives. By targeting the disregulated JAK pathway, Jakavi delivers a rapid and durable benefit that has the potential to become a new standard of care.”
Dr. Claire Harrison, MD, Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London.
“This approval marks a significant milestone in addressing unmet treatment needs for patients in the European Union. We are committed to the development of innovative treatments for orphan diseases, and are furthering research to assess the potential of targeted Jakavi therapy for other malignancies associated with a dysregulated JAK pathway.”
Hervé Hoppenot, President, Novartis Oncology
By targeting the underlying mechanism of disease, Jakavi® reduced spleen size and debilitating manifestations of myelofibrosis, in Phase III studies.
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