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▎The content team editor of WuXi AppTec recently announced on the official website of China National Medical Products Administration (NMPA) that Biogen's dimethyl fumarate (English trade name: Tecfidera; English common name: dimethyl fumarate) enteric-coated capsules The marketing application was officially approved for the treatment of relapsing multiple sclerosis (MS).
Image source: CDE official website about multiple sclerosis Multiple sclerosis is a lifelong and progressive autoimmune central nervous system disease.
The patient's immune system attacks the myelin sheath that protects nerve fibers, causing the nerves to fail to conduct electrical signals normally, affecting the brain and body Other parts of the communication.
Eventually, the nerve itself will also degenerate.
In the human body, most nerve fibers are wrapped with an insulating layer called "nerve myelin.
"
On the one hand, it can protect nerve fibers, and on the other hand, it can also ensure the accuracy of signal transmission.
However, sometimes the immune system will point its gun at the central nervous system and launch a series of attacks.
These attacks are unpredictable and bloom at multiple points, causing the nerve myelin sheath to continue to break and fall off, and gradually cause the patient's spinal cord, brain and optic nerve function to be damaged.
Research data from the Multiple Sclerosis International Federation (MSIF) shows that 1 out of every 3000 people in the world suffers from multiple sclerosis; the average age of onset is 30 years old, and it is rare for patients under 10 and over 50 years old; female prevalence rate Higher than men, the ratio of female to male is (1.
4～2.
3):1; this disease is also the second leading cause of non-traumatic neurological disability in young adults.
The cause of multiple sclerosis is currently unclear.
Scientists believe that multiple sclerosis may be a disease caused by multiple factors.
Under the influence of genetic and environmental factors, it develops through autoimmune reactions.
Infection, trauma, pregnancy, surgery, and poisoning can all be its triggers.According to the course of the disease, multiple sclerosis can be divided into 4 types-relapsing remitting type (RRMS), secondary progressive type (SPMS), primary progressive type (PPMS) and progressive relapsing type (PRMS), of which relapsing remitting type is the most common The type of disease is manifested as the periodic recurrence and remission of the disease.
Picture source: 123RF about dimethyl fumarate Dimethyl fumarate is an oral preparation developed by Bojian Company.
In September 2019, Bojian Company announced the latest 10-year treatment data of the drug, proving that the drug can bring long-term stable benefits to patients with multiple sclerosis.
According to Bojian’s press release, the China National Medical Products Administration’s assessment referred to relevant data from the world’s key Phase 3 DEFINE and CONFIRM studies, which enrolled more than 2,600 patients.
The results of the DEFINE study showed that when used for 2 years, dimethyl fumarate (twice a day) significantly reduced the annual recurrence rate by 53% compared with placebo.
The results of the CONFIRM study showed that compared with placebo, dimethyl fumarate (twice a day) significantly reduced the proportion of relapsed patients by 34% when used for 2 years.
In 2013, dimethyl fumarate was approved by the U.
S.
FDA for the treatment of multiple sclerosis.
Today, the drug has become one of the most widely used oral drugs in the treatment of multiple sclerosis in the world, and more than 500,000 patients have received the treatment of dimethyl fumarate.
Image source: 123RF congratulates the official approval of dimethyl fumarate in China, which means that this drug, which has benefited many patients, will come to Chinese patients with multiple sclerosis, and they will soon usher in a new treatment option.
At the same time, we should also note that although there are more than a dozen treatments for multiple sclerosis, we still have a certain distance to stop the disease progression.
We look forward to the successful research and development of more drugs to treat and even cure multiple sclerosis, so that more patients will be free from the suffering of the disease! Recommended reading for the listing of icatibant acetate! Nearly 30,000 patients with hereditary angioedema in China usher in a new era of acute treatment drugs! China's first precision treatment drug for gastrointestinal stromal tumors was approved for precision treatment of lung cancer, and China's first RET inhibitor, pratinib, was approved.
Utidelon was approved for listing in China: new opportunities for advanced breast cancer treatment, recommended by CSCO guidelines! Sofantinib was approved for the treatment of non-pancreatic neuroendocrine tumors, and the charity aid project was launched at the same time.
Reference materials [1] April 15, 2021.
Drug approval documents pending information release.
Retrieved Apr 16, 2021, from https://www .
nmpa.
gov.
cn/zwfw/sdxx/sdxxyp/yppjfb/20210415154452160.
html[2] NEW DATA PRESENTED AT ECTRIMS REINFORCE LONG-TERM BENEFITS OF TECFIDERA® (DIMETHYL FUMARATE) OVER 10 YEARS.
Retrieved Apr 16, 2021, from ://investors.
biogen.
com/news-releases/news-release-details/new-data-presented-ectrims-reinforce-long-term-benefits[3] Biogen's dimethyl fumarate enteric-coated capsules are in Hua is approved for the treatment of relapsing multiple sclerosis.
Retrieved Apr 16, 2021, from https://mp.
weixin.
qq.
com/s/pr0OwfVwnekC1SaKKQ-PCw[4] Guidelines for the diagnosis and treatment of rare diseases (2019 edition) Note: This article aims to Introduce medical and health research progress, not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
Image source: CDE official website about multiple sclerosis Multiple sclerosis is a lifelong and progressive autoimmune central nervous system disease.
The patient's immune system attacks the myelin sheath that protects nerve fibers, causing the nerves to fail to conduct electrical signals normally, affecting the brain and body Other parts of the communication.
Eventually, the nerve itself will also degenerate.
In the human body, most nerve fibers are wrapped with an insulating layer called "nerve myelin.
"
On the one hand, it can protect nerve fibers, and on the other hand, it can also ensure the accuracy of signal transmission.
However, sometimes the immune system will point its gun at the central nervous system and launch a series of attacks.
These attacks are unpredictable and bloom at multiple points, causing the nerve myelin sheath to continue to break and fall off, and gradually cause the patient's spinal cord, brain and optic nerve function to be damaged.
Research data from the Multiple Sclerosis International Federation (MSIF) shows that 1 out of every 3000 people in the world suffers from multiple sclerosis; the average age of onset is 30 years old, and it is rare for patients under 10 and over 50 years old; female prevalence rate Higher than men, the ratio of female to male is (1.
4～2.
3):1; this disease is also the second leading cause of non-traumatic neurological disability in young adults.
The cause of multiple sclerosis is currently unclear.
Scientists believe that multiple sclerosis may be a disease caused by multiple factors.
Under the influence of genetic and environmental factors, it develops through autoimmune reactions.
Infection, trauma, pregnancy, surgery, and poisoning can all be its triggers.According to the course of the disease, multiple sclerosis can be divided into 4 types-relapsing remitting type (RRMS), secondary progressive type (SPMS), primary progressive type (PPMS) and progressive relapsing type (PRMS), of which relapsing remitting type is the most common The type of disease is manifested as the periodic recurrence and remission of the disease.
Picture source: 123RF about dimethyl fumarate Dimethyl fumarate is an oral preparation developed by Bojian Company.
In September 2019, Bojian Company announced the latest 10-year treatment data of the drug, proving that the drug can bring long-term stable benefits to patients with multiple sclerosis.
According to Bojian’s press release, the China National Medical Products Administration’s assessment referred to relevant data from the world’s key Phase 3 DEFINE and CONFIRM studies, which enrolled more than 2,600 patients.
The results of the DEFINE study showed that when used for 2 years, dimethyl fumarate (twice a day) significantly reduced the annual recurrence rate by 53% compared with placebo.
The results of the CONFIRM study showed that compared with placebo, dimethyl fumarate (twice a day) significantly reduced the proportion of relapsed patients by 34% when used for 2 years.
In 2013, dimethyl fumarate was approved by the U.
S.
FDA for the treatment of multiple sclerosis.
Today, the drug has become one of the most widely used oral drugs in the treatment of multiple sclerosis in the world, and more than 500,000 patients have received the treatment of dimethyl fumarate.
Image source: 123RF congratulates the official approval of dimethyl fumarate in China, which means that this drug, which has benefited many patients, will come to Chinese patients with multiple sclerosis, and they will soon usher in a new treatment option.
At the same time, we should also note that although there are more than a dozen treatments for multiple sclerosis, we still have a certain distance to stop the disease progression.
We look forward to the successful research and development of more drugs to treat and even cure multiple sclerosis, so that more patients will be free from the suffering of the disease! Recommended reading for the listing of icatibant acetate! Nearly 30,000 patients with hereditary angioedema in China usher in a new era of acute treatment drugs! China's first precision treatment drug for gastrointestinal stromal tumors was approved for precision treatment of lung cancer, and China's first RET inhibitor, pratinib, was approved.
Utidelon was approved for listing in China: new opportunities for advanced breast cancer treatment, recommended by CSCO guidelines! Sofantinib was approved for the treatment of non-pancreatic neuroendocrine tumors, and the charity aid project was launched at the same time.
Reference materials [1] April 15, 2021.
Drug approval documents pending information release.
Retrieved Apr 16, 2021, from https://www .
nmpa.
gov.
cn/zwfw/sdxx/sdxxyp/yppjfb/20210415154452160.
html[2] NEW DATA PRESENTED AT ECTRIMS REINFORCE LONG-TERM BENEFITS OF TECFIDERA® (DIMETHYL FUMARATE) OVER 10 YEARS.
Retrieved Apr 16, 2021, from ://investors.
biogen.
com/news-releases/news-release-details/new-data-presented-ectrims-reinforce-long-term-benefits[3] Biogen's dimethyl fumarate enteric-coated capsules are in Hua is approved for the treatment of relapsing multiple sclerosis.
Retrieved Apr 16, 2021, from https://mp.
weixin.
qq.
com/s/pr0OwfVwnekC1SaKKQ-PCw[4] Guidelines for the diagnosis and treatment of rare diseases (2019 edition) Note: This article aims to Introduce medical and health research progress, not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
