Lemtrada (alemtuzumab) is a treatment option for patients with relapsing multiple sclerosis (MS) who have not adequately responded to two or more other drugs for treating MS. Genzyme, a Sanofi company, received approval for Lemtrada from the U.S. Food and Drug Administration (FDA) in November 2014.
How does Lemtrada work?1
Monoclonal antibodies – such as alemtuzumab – are designed to detect specific types of substances in the body, and can then act on that substance via some kind of mechanism such as binding to cells, eliminating cells, or blocking certain molecular functions. In the case of Lemtrada, alemtuzumab targets a protein called CD52 that is plentiful on T and B cells, which are also known as lymphocytes or white blood cells. Researchers believe that T and B lymphocytes circulating in the body may be involved in the harmful inflammatory process that characterizes MS. Lemtrada was therefore designed to function by depleting the number of T and B lymphocyte cells circulating in the body after each course of treatment.
According to the results of clinical trials that led to its approval from the FDA, Lemtrada is effective in reducing the rates of relapse in patients with MS. There are also indications that Lemtrada may also slow the progression of disability in some types of MS patients. More information about the clinical data demonstrating the effectiveness of Lemtrada is available here.
During the clinical trial phase, treatment with Lemtrada was linked to several very serious risks and side effects, some of which may be life threatening. Because of these safety concerns, Lemtrada is only recommended for patients who have tried treatment with two or more other types of MS drugs, but have not experienced satisfactory results from those regimens. More information about the serious risks and side effects that are associated with Lemtrada is available here.
Dosing and Administration2
Lemtrada is administered to patients via intravenous infusion during treatment courses once per year for two years. In the first course, a total dose of 60 mg is delivered during a span of five consecutive days – patients receive 12 mg per day over four hours each day. The second course is delivered a year later, with patients receiving 12 mg per day (36-mg total dose) via four-hour intravenous infusions for three consecutive days.
Safety and Support Programs for Patients1
Due to concerns about Lemtrada’s safety, it is only accessible to patients in the U.S. through a restricted distribution program called Lemtrada REMS (Risk Evaluation and Mitigation Strategy). The REMS system is designed to provide patients and healthcare providers with comprehensive information about the serious risks that are associated with Lemtrada treatment. The program was implemented to make sure that patients can only be prescribed Lemtrada through certified healthcare providers, that it is available only in specialty pharmacies, and that it is administered correctly in a certified facility. The REMS program also requires that patients be enrolled in the program in order to receive treatment, and ensures that they are regularly and appropriately monitored to detect any of the possible risks for four years after the last course of treatment.
Genzyme offers a support program called MS One to One to provide information about MS, treatment with Lemtrada, and its associated risks. The program provides a way for MS patients, their friends and family, and their healthcare providers to seek advice from experts such as MS specialist nurses or other qualified professionals. To utilize the MS One to One program, or to find out more about it, the website address is www.MSOnetoOne.com. Phone service is also available weekdays from 8:30AM – 8:00PM ET at 1-855-MSOne2One (855-676-6326).
Lemtrada is Genyzme’s second treatment for relapsing types of MS to gain approval from the FDA, joining once-daily oral therapy Aubagio (teriflunomide), which has a different mechanism of action. Alemtuzumab, the active agent in Lemtrada, is also used to under a different brand name (Campath, also marketed by Genzyme) to treat chronic lymphocytic leukemia by targeting T and B lymphocytes.