Novartis - Gilenya: Growing Clinical Evidence on safety and efficacy, together with growing physician comfort will help maintain growth in a competitive space
Subsequent to successful data from FREEDOM and TRANSFORM studies, NVS today reported third positive data from 2309 study (PhIII-FREEDOM II) which enrolled approximately 1083 patients. The 24 m data showed that Gilenya (0.5 mg) had significantly reduced the annualized relapse rate by 48% than placebo. The study also met key secondary endpoint of confirmed disability of progression measured by EDSS scale (17% at 3 m and 28% at 6m) which was not statistically significant. It was attributed to ........... In addition, it also demonstrated high efficacy in MRI measure. It is good to note that this large study did not throw any new safety signal even after 24 m as it was intended to provide safety data to FDA. The complete data is expected ........... ~80% of neurologists are now prescribing Gilenya, which was improved from 65% reported six months after launch and Among the late stage pipeline molecules, Biogen Idec’s BG-12 poses immediate threat to Gilenya..................
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