French drug major Sanofi (Euronext: SAN) and its subsidiary Genzyme presented positive new data from the Lemtrada (alemtuzumab) clinical development program in multiple sclerosis at the 66th American Academy of Neurology (AAN) Annual Meeting.
In Lemtrada patients from the two Phase III clinical trials (both treatment-naive patients and patients who had active disease on another therapy), MRI effects observed after two years were maintained during the first year of the extension study. The data demonstrated consistent effects across key measures of disease activity (gadolinium (gd)-enhancing, T2 hyperintense and T1 hypointense lesion activity) and effects seen after two years of treatment were sustained at year three and during the third year of follow-up, more than 70% of patients were free of MRI activity indicative of acute inflammation, defined as gd-enhancing or new or enlarging T2 hyperintense lesions.
In addition, T2 lesion volumes, which reflect the combined burden of permanent brain injury and new lesion formation, increased from year two to three but remained below pre-treatment baseline. The rate of atrophy, as measured by brain parenchymal fraction, already reduced after two years, continued to slow in the third year of follow-up. Around 80% of patients treated with Lemtrada did not receive a third course of treatment in the first year of the extension.
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