Multiple Sclerosis (MS) is a chronic condition affecting the brain and spinal cord, impacting nerve signal transmission and leading to a range of symptoms. Sanofi Genzyme, a global biopharmaceutical company, plays a role in developing treatments for this complex neurological disorder. Their research and development efforts focus on addressing the inflammatory and neurodegenerative aspects of MS.
Sanofi Genzyme’s MS Treatment Portfolio
Sanofi Genzyme offers specific medications designed to manage relapsing forms of multiple sclerosis. Two notable treatments in their portfolio are Aubagio (teriflunomide) and Lemtrada (alemtuzumab). Both drugs aim to reduce the frequency of relapses and slow disease progression in adults with MS.
Aubagio is an oral medication, classified as a pyrimidine synthesis inhibitor. This once-daily pill provides a convenient administration option for patients. Lemtrada is an intravenous (IV) infusion, a type of monoclonal antibody.
Mechanisms of Action
Aubagio (teriflunomide) works by inhibiting a mitochondrial enzyme called dihydroorotate dehydrogenase, which is involved in de novo pyrimidine synthesis. While the precise mechanism in MS is not fully understood, this action is thought to reduce the number of activated lymphocytes, a type of white blood cell, within the central nervous system. By limiting the multiplication of these immune cells, Aubagio helps to decrease the inflammation associated with MS.
Lemtrada (alemtuzumab) is a humanized monoclonal antibody that targets CD52, a protein found on the surface of T and B lymphocytes, as well as other immune cells. By binding to CD52, Lemtrada triggers antibody-dependent cellular cytotoxicity and complement-mediated lysis, leading to the depletion of these circulating lymphocytes. This depletion and subsequent repopulation of lymphocytes over time are believed to rebalance the immune system, reducing autoimmune activity and the potential for MS relapses.
Patient Suitability and Usage
Aubagio (teriflunomide) is approved for adults with relapsing forms of MS, which include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is administered as an oral tablet, typically taken once daily at either a 7 mg or 14 mg dose. The usual starting dose for MS is 7 mg once per day, which a doctor may increase to 14 mg if the initial dosage does not yield sufficient results.
Lemtrada (alemtuzumab) is indicated for adults with relapsing forms of MS, specifically relapsing-remitting disease and active secondary progressive disease. Its use is generally reserved for patients who have not responded adequately to two or more prior MS therapies due to its safety profile. Lemtrada is administered intravenously in two distinct treatment courses. The first course involves daily 12 mg infusions for five consecutive days, followed by a second course of daily 12 mg infusions for three consecutive days, administered 12 months after the first. Subsequent courses, if needed, can be given at least 12 months after the previous one, also consisting of three consecutive daily infusions.
Safety Considerations
Both Aubagio and Lemtrada carry important safety considerations that require careful monitoring. Aubagio (teriflunomide) has a boxed warning for potential liver damage, including acute liver failure, and for embryofetal toxicity. Patients taking Aubagio may experience common side effects such as headaches, diarrhea, nausea, hair thinning or loss, and increased liver enzyme levels. More serious, but less common, side effects can include low white blood cell counts, which may increase infection risk, peripheral neuropathy, and severe skin reactions. Liver enzyme levels are assessed monthly for the first six months of treatment and periodically thereafter.
Lemtrada (alemtuzumab) is associated with several serious risks, including serious autoimmune conditions, infusion reactions, and certain cancers. Autoimmune problems, such as immune thrombocytopenia and thyroid disorders, can occur months to years after treatment. Infusion reactions, which can be severe and occur during or up to 24 hours after infusion, are common and may include headache, fever, rash, nausea, and changes in heart rate. Patients receiving Lemtrada require comprehensive monitoring, including complete blood counts, serum creatinine levels, and urinalysis, at monthly intervals for up to 48 months after the last dose to detect potential autoimmune issues.