Novartis Secures EU Approval for Tasigna Treatment in Children
20 November 2017 - 6:33PM
Dow Jones News
By Alberto Delclaux
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.
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)
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