Novartis Secures EU Approval for Tasigna Treatment in Children

By Alberto Delclaux Features Dow Jones Newswires

Novartis AG (NOVN.EB) said Monday that its drug Tasigna secured European Union approval for first and second-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, or Ph+ CML-CP, in children.

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It means Tasigna is the only second-generation tyrosine kinase inhibitor currently approved in the EU for this treatment in children, Novartis said. The approval follows a positive opinion issued on Sep. 14 by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Chronic Myeloid Leukemia, or CML, is responsible for approximately 10% to 15% of all adult cases of Leukemia, with an incidence of one to two cases per 100,000 a year, Novartis said. Almost all patients with CML have an abnormality known as the Philadelphia chromosone it added.

Write to Alberto Delclaux at alberto.delclaux@dowjones.com

(END) Dow Jones Newswires

November 20, 2017 02:18 ET (07:18 GMT)