Genzyme's Lemtrada For MS Approved By The FDA

Sanofi’s subsidiary Genzyme announced that Lemtrada (alemtuzumab) has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with relapsing forms of multiple sclerosis (MS).

Lemtrada is a human monoclonal antibody (mAb) designed to target CD52, a protein highly expressed on T and B cells. Alemtuzumab works by depleting circulating T and B lymphocytes, which are implicated in the damaging inflammatory process in multiple sclerosis. Treatment with Lemtrada aims to rebalance the immune system in a way that reins in multiple sclerosis activity.

The FDA approved Lemtrada particularly for patients who have had an inadequate response to two or more drugs for multiple sclerosis. The decision was supported by positive results from two pivotal Phase 3 open-label rater-blinded studies comparing Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with RRMS who were either treatment-naïve (CARE-MS I) or who had suffered while on prior therapy (CARE-MS II). Results show that Lemtrada demonstrated significantly greater efficacy than Rebif at cutting annualized relapse rates in both CARE-MS I and CARE-MS II. Earlier this year, the company also released positive interim results from an extension study showing that 70 percent of Lemtrada-treated patients improved or maintained their disability scores for two years after the two Phase 3 trials.

Genzyme President and CEO, David Meeker, said, “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada. Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks identified with treatment.” The Lemtrada REMS (Risk Evaluation and Mitigation Strategy) distribution program aims to help educate physicians and patients alike on Lemtrada’s associated risks, which include infections, pneumonitis autoimmune thyroid disease, and autoimmune cytopenias.

“The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States. We are pleased that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option,” said Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society.

The Boston Globe reports that Genzyme execs revealed Lemtrada’s price tag to be $158,000 for two courses of treatment over two years. Though the price is slightly higher than rival treatments, such as Rebif ($134,600), Genzyme points out that patients taking Lemtrada suffered 50 percent fewer relapses compared to those taking other current treatments.