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Novartis's Jakavi gets EU polycythemia vera indication

This article was originally published in Scrip

Executive Summary

The European Commission has approved Novartis's oral JAK 1 and 2 tyrosine kinase inhibitor Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea, making it the first targeted treatment approved in the EU for this patient population. The approval adds to that already received for the product in the EU and elsewhere for myelofibrosis, and follows the December supplemental approval for polycythemia vera in the US, where it is marketed by Incyte as Jakafi. The polycythemia vera approvals were based on data from the Phase III RESPONSE trial in which the drug significantly improved hematocrit as well as symptom control and reduced spleen size in patients with the rare and incurable blood cancer who were resistant to or intolerant of hydroxyurea. The EU application received a positive opinion from the CHMP in January.



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