Bristol-Myers Squibb receives EU approval for CML treatment
13 December 2010 00:00 in Pharmaceutical Company Product News
Bristol-Myers Squibb has been granted approval from the European Commission to market its drug Sprycel as a treatment for certain cases of chronic myelogenous leukaemia (CML).
The pharmaceutical firm's product has been given marketing authorisation as a once-daily first-line therapy for use among adult patients with newly-diagnosed Philadelphia chromosome-positive variants of the fatal disease.
This approval was granted following regulatory analysis of data from the recent Dasison clinical trial, in which the treatment was shown to offer superior performance compared to a leading alternative.
Sprycel has been sanctioned as a therapy for CML patients with resistance or intolerance to other drugs since November 2006.
Elliott Sigal, executive vice-president, chief scientific officer and president of research and development at Bristol-Myers Squibb, said: "The marketing authorisation by the European Commission is an important development for CML patients and their physicians in Europe."
Last month, the company published new data from a clinical trial which showcased the benefits of its new HIV drug Reyataz.
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