Genzyme Seeks Approval for Multiple Sclerosis Drug Lemtrada

Sanofi's Genzyme unit announced in a press release earlier last week that the company has submitted an application to regulatory authorities for approval of Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS).

Sanofi’s Genzyme unit announced in a press release earlier last week that the company has submitted a supplemental Biologics License Application to the FDA and a marketing authorization application to the European Medicines Agency (EMA) seeking approval of Lemtrada for the treatment of relapsing multiple sclerosis (RMS).

In clinical trials, Lemtrada outperformed other treatments containing high-dose subcutaneous interferon beta-1a. In both CARE-MS I and CARE-MS II trials, Lemtrada 12 mg was given intravenously a total of 8 times over the course of the 2-year study. In the CARE-MS I trial, the drug reduced the number of relapses by 78% and reduced the risk of disability by 71%.

“There remains a large unmet treatment need for patients living with active disease and we believe that Lemtrada, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with MS,” said David Meeker, Genzyme president and CEO.

Lemtrada is a monoclonal antibody that has been used since the 1980s to treat chronic lymphocytic leukemia. Early alemtuzumab research has shown T and B cell lymphocyte repopulation following alemtuzumab treatment for MS.

In addition to Lemtrada, Genzyme has the once-daily oral treatment Aubagio (teriflunomide) for RMS in the pipeline. Genzyme said that this drug is currently under review by the FDA and EMA, and according to reports, Aubagio cuts the annualized relapse rate of MS by 36.3% relative to placebo.