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In March 2017, ocrelizumab was approved in the United States for the treatment of primary progressive multiple sclerosis in adults. [22] [42] It is also used for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. [42]
In February 2016, the US Food and Drug Administration (FDA) granted breakthrough therapy designation for primary progressive multiple sclerosis. [21] In March 2017, the FDA approved ocrelizumab for relapsing-remitting and primary-progressive multiple sclerosis. It is the first FDA-approved treatment for the primary progressive form.
Multiple sclerosis (MS) is an autoimmune disease resulting in damage to the insulating covers of nerve cells in the brain and spinal cord. [3] As a demyelinating disease, MS disrupts the nervous system's ability to transmit signals, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems.
Usually the regulatory agencies approve a multiple sclerosis medication for a specific clinical course. Treatments for RRMS (relapsing-remitting), SPMS (secondary progressive), or PPMS (primary progressive) are common.
Clinical trial number NCT05232825 for "A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis (Ocarina II)" at ClinicalTrials.gov
Advancements during the last decades have led to the recent approval of several oral drugs. In March 2019 for example the Food and Drug Administration approved cladribine tablets (Mavenclad) to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. [29]
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