Dimethyl fumarate is given priority review and approval in China for the benefit of MS patients

Zhongxin Online, April 16 (Reporter Chen Jing) Recurrent multiple sclerosis (ms) is a lifelong, progressive autoimmune central nervous system disease, which is an important cause of non-traumatic nervous system disability in young adults. Individualized treatment is essential.

The reporter learned on the 16th that the State Drug Administration of China officially approved dimethyl fumarate enteric-coated capsules (dimethyl fumarate) for the treatment of recurrent multiple sclerosis (ms) through the priority review and approval procedure. This will provide entirely new treatment options for Chinese patients.

Professor Wang Yongjun, deputy director of the National Clinical Research Center for Neurological Diseases and chairman of the Neurology Branch of the Chinese Medical Association, said in an interview with reporters on the 16th that the central nervous system of MS patients gradually caused limb disabilities, and neurological dysfunction such as movement, vision and cognition appeared. Without timely and standardized treatment, most ms patients will be disabled by irreversible neurological deficits.

The severity of ms and specific symptoms vary from person to person. Recurrent ms is the most common type of the disease, with about 85% of patients being diagnosed with this type. At present, multiple sclerosis is internationally treated with disease modification therapy (DMT) as the standard of treatment. "Ms pathological features, clinical manifestations and course are highly heterogeneous, and individualized treatment is essential," the expert said. ”

It is reported that dimethyl fumarate was first listed in 2013, and about 10 years of clinical trials and real-world data show that it has exact safety and efficacy. To date, more than hundreds of thousands of people with multiple sclerosis worldwide have been treated with dimethyl fumarate. It is understood that among the patients diagnosed with multiple sclerosis in China, there are very few who are receiving disease correction treatment.

It is understood that the assessment of the State Drug Administration refers to the relevant data of relevant global key studies. The results of the study showed that dimethyl fumarate significantly reduced the annual recurrence rate by 53% compared with placebo after two years of use. Wang Yongjun pointed out that the results of clinical trials and more than a decade of real-world evidence have fully verified the efficacy, safety and tolerability of 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, aiming to support the diagnosis and treatment of rare diseases. The NMPA initiates a priority review and approval process for relevant innovative drugs, using clinical trial evidence from developed country markets to evaluate these innovative therapies. 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.

Wang Yongjun said that the approval of dimethyl fumarate and its clinical application will bring new choices to patients and enrich the clinical treatment experience of Ms in China, so that more patients can benefit. Rachid izzar, president of the relevant multinational pharmaceutical company market, said that being able to bring this mature treatment plan to patients with relapsed multiple sclerosis in China is an important milestone for the company, which will work with Chinese people concerned about multiple sclerosis to solve unmet treatment needs and bring more innovative treatment options to China. (End)

Source: China News Network