The Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first injectable biosimilar to Tysabri (natalizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Newer drugs for treating multiple sclerosis include Briumvi, Ponvory, Kesimpta, Bafiertam, Zeposia, Vumerity, Mavenclad, Mayzent, and Ocrevus. Briumvi is the third CD20 multiple sclerosis drug approved by the FDA, along with ocrelizumab (Ocrevus) and ofatumumab (Kesimpta). Briumvi has a mechanism of action similar to that of Ocrevus and Kesimpta, but it has a slightly different goal, says Daniel Ontaneda, MD, PhD, a physician at the Cleveland Clinic's Mellen Center for MS.
Ontaneda was not involved in the trials. Avonex is approved by the US. UU. Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS with relapses).
Betaseron and Extavia are approved by the US. Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults. Glatopa is approved by the US. Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Plegridy is approved by the FDA for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS with relapses). Rebif is approved for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS with relapses). Dimethylfumarate delayed-release capsules are approved by the FDA for the treatment of relapsing forms of multiple sclerosis, and include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. The FDA has approved Lemtrada for the treatment of relapsing forms of multiple sclerosis, including relapsing remitting disease and active secondary progressive disease, in adults.
Dimethylfumarate is a formulation that was developed specifically for use in people with multiple sclerosis. Because of its safety profile, the use of Mavenclad is generally recommended in patients who have had an inadequate response or who cannot tolerate an alternative drug indicated for the treatment of MS. The FDA has approved Vumerity for the treatment of relapsing forms of multiple sclerosis, and it includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age or older.
Tecfidera, formerly known as BG-12, is dimethyl fumarate, a formulation that was developed specifically for use in people with multiple sclerosis. Phase II studies are conducted in medium-sized patient groups (20 to 300) and are designed to evaluate if a drug works in the target disease area, as well as to continue previous safety evaluations obtained in healthy volunteers. Glycoengineering means eliminating certain sugar molecules that are normally expressed in the antibody, which is believed to increase the potency of the drug. There is no cure for multiple sclerosis (MS), but much progress has been made in the development of new drugs to treat it.
Food and Drug Administration; IV %3D intravenously; MS%3D multiple sclerosis; PRMS%3D relapsing primary multiple sclerosis; RRMS %3D relapsing-remitting multiple sclerosis; SPMS %3D secondary progressive multiple sclerosis. The Food and Drug Administration (FDA) approved Briumvi (ublituximab), a disease-modifying treatment (DMT) to treat relapsing forms of multiple sclerosis (RMS) in adults, such as clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Sometimes they approve it for a subtype, such as highly active MS (HAMS, within the RRMS), rapidly worsening MS (RWMS, within the PPMS), or active SPMS (previous progressive relapse). .
