MS DIGEST – Nov. 14, 2014 – The FDA today announced it has approved LemtradaTM (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS.
The approval of was based on two randomized clinical trials comparing Lemtrada to Rebif® (high-dose interferon) where those assessing patients for relapse did not know which drug the patient was receiving.
In the CARE-MS I trial, of 187 patients in the interferon group who were assessed, 75 (40 percent) relapsed compared with 82 (22 percent) of the 376 assessed in the alemtuzumab group. After two years 78 percent of patients in the alemtuzumab group were relapse-free compared with 59 percent of patients in the interferon group.
In the (CARE-MS II) trial 104 of 202 assessed patients (51 percent) in the interferon group relapsed compared to 147 of 426 (35 percent) in the alemtuzumab group. In the the alemtuzumab group 65 percent of patients were relapse-free at two years compared with 47 percent of interferon group.
The Lemtrada label includes a boxed warning of serious and life-threatening autoimmune conditions such as immune thrombocytopenia (ITP) and anti-glomerular basement membrane disease can occur in patients receiving Lemtrada. For this reason it is recommended for those who have had inadequate response to two or more drugs for treatment of their MS.
Lemtrada was developed by Genzyme, which is owned by pharmaceutical maker Sanofi.
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