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Treatment in MS Phase III studies is usually two years per patient. In July 2021, the FDA gave the go-ahead for an investigational new drug application (IND) for the phase 3 ENSURE program, which will evaluate IMU-838 in patients with relapsing-remitting multiple sclerosis (RRMS).
Interferon beta-1a (also interferon beta 1-alpha) is a cytokine in the interferon family used to treat multiple sclerosis (MS). [5] It is produced by mammalian cells, while interferon beta-1b is produced in modified E. coli. [6] Some research indicates that interferon injections may result in an 18–38% reduction in the rate of MS relapses. [7]
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]
The Monthly Index of Medical Specialities or MIMS is a pharmaceutical prescribing reference guide published in the United Kingdom since 1959 by Haymarket Media Group.MIMS is also published internationally by various organisations, including in Australia, New Zealand, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam.
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
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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.
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