Beijing News (reporter Zhang Xiulan) on April 16, Bojian Company announced that dimethyl fumarate enteric-coated capsules (hereinafter referred to as dimethyl fumarate) have been approved by the State Food and Drug Administration for the treatment of recurrent multiple sclerosis. The drug has been included in the list of new drugs urgently needed abroad in clinical practice.
Multiple sclerosis (hereinafter referred to as ms) is a lifelong, progressive autoimmune central nervous system disease, which is mainly characterized by the gradual disability of limbs caused by central nervous system involvement, and the emergence of neurological dysfunction such as motor, visual and cognitive. If not treated in a timely manner, most patients will be disabled by irreversible neurological deficits. The data shows that only about 10% of patients diagnosed with multiple sclerosis in China are receiving disease modification treatment. Ms is the second leading cause of non-traumatic neurological disability in young adults, with recurrent ms being the most common type of disease, with about 85% of patients being diagnosed with this type.
"Internationally, multiple sclerosis uses disease modification therapy (DMT) as the standard of treatment." Professor Wang Yongjun, president of Beijing Tiantan Hospital affiliated to Capital Medical University, said that ms pathological characteristics, clinical manifestations and course of disease have strong heterogeneity, and individualized treatment is crucial. Clinical trial results and more than a decade of real-world evidence have amply validated the efficacy, safety and tolerability of dimethyl fumarate.
Dimethyl fumarate was first marketed in 2013. To date, more than 500,000 people with multiple sclerosis worldwide have been treated with dimethyl fumarate. In May 2018, ms was included in the "First Catalogue of Rare Diseases" jointly formulated by the National Health Commission and other five departments. In November 2020, dimethyl fumarate was included in the third batch of clinically urgently needed overseas new drugs by the Drug Evaluation Center of the State Drug Administration.
Proofreading By Chen Diyan
Source: Beijing News