Jakavi will be the first EU approved JAK inhibitor developed to treat patients
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Jakavi (INC424, ruxolitinib) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Globally, there are few available treatments for myelofibrosis, an uncommon, life-threatening blood cancer characterised by multiple severe complications such as bone marrow failure, enlarged spleen (splenomegaly) and shortened survival.
Hervé Hoppenot, President, Novartis Oncology said, “The Committee’s positive opinion today validates the strong data in support of Jakavi and the very high unmet need in treating myelofibrosis. The recommendation for European Commission approval of Jakavi also marks a significant step forward in bringing the first and only JAK 1 and JAK 2 inhibitor to patients with very limited options. Novartis is committed to advancing novel, targeted treatments for rare diseases, and we are invested in continuing research to determine other haematological diseases where Jakavi may address unmet patient needs.”
In the European Union (EU), the European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation. The decision will be applicable to all 27 EU member states. The European Commission granted Jakavi orphan drug designation for myelofibrosis.
The CHMP opinion was based on positive findings from the COMFORT (Controlled MyeloFibrosis Study with ORal JAK Inhibitor Therapy) programme, which represents the largest myelofibrosis clinical development programme to date.
Jakavi directly targets the underlying mechanism of disease, significantly reducing splenomegaly and improving symptoms regardless of JAK mutational status, disease subtype or any prior
treatment, including hydroxyurea.
EP News Bureau — Mumbai
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