Sanofi company Genzyme announced it has launched its newly approved drug Lemtrada (alemtuzumab) as treatment for multiple sclerosis in the U.S.
Alemtuzumab is a human monoclonal antibody (mAb) that targets the protein CD52, which is highly expressed on T and B cells. The drug’s mechanism of action depletes circulating lymphocytes thought to drive the damaging inflammatory process in multiple sclerosis. Therapy with Lemtrada is considered to rebalance the immune system in a way that dampens MS activity. The FDA approved Lemtrada last month as treatment for relapsing forms of multiple sclerosis (MS).
The approval was based on positive results from two pivotal late stage trials which pitted Lemtrada against Rebif, a high-dose subcutaneous interferon beta-1a, in patients with RRMS. Data showed that Lemtrada was significantly more effective than Rebif in reducing annualized relapse rates. “As an investigator in the Phase 3 clinical development program with firsthand experience, I have been awaiting the ability to prescribe Lemtrada to patients in my practice who could potentially benefit from this treatment,” said Christopher LaGanke, founder of North Central Neurology Associates in Cullman, Ala.
Genzyme cautions physicians that Lemtrada should be generally used for patients who have shown insufficient response to two or more standard treatments for MS. The drug is exclusively available through the Lemtrada REMS (Risk Evaluation and Mitigation Strategy) intended to ensure early detection and management of several serious risks associated with alemtuzumab treatment, including the development of thyroid cancer, melanoma, and lymphoproliferative disorders, and sometimes fatal autoimmune conditions. Other risks include pneumonitis, infections, autoimmune thyroid disease, and autoimmune cytopenias.
“Since approval, we have been singularly focused on providing access as quickly as possible for those patients awaiting Lemtrada by ensuring drug availability, completing required REMS training and certifications, and establishing appropriate patient support,” said Bill Sibold, Head of Genzyme’s Multiple Sclerosis business.