BASEL (dpa-AFX) - Novartis International AG (NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.
The company said global regulatory applications for ruxolitinib in polycythemia vera are currently ongoing, and further regulatory filings are under review by health authorities. Ruxolitinib, which is marketed in the US by Incyte Corporation as Jakafi, received approval in December 2014 from the US FDA for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
Copyright RTT News/dpa-AFX