Lemtrada Not Approved

FDA has taken the position that the Lemtrada clinical trials were not adequate and well-controlled.  Patients in the trial were assigned to alemtuzumab (Lemtrada) infusions or Rebif injections.  Patients did not receive placebo infusions or placebo injections so the FDA was concerned that knowing which treatment a person was receiving would bias the result.  Due to infusion reactions with Lemtrada and interferon side effects, a trial where patients were truly blinded would have been very difficult.  Nonetheless,  that FDA stated that one or more additional active comparator clinical trials would need to be performed for approval.  Lemtrada has recently been approved in Europe, Canada and Australia.

Read Genzyme Press Release.

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