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Date: 19-Apr-2021

China NMPA Approves Biogen’s Tecfidera To Treat Multiple Sclerosis

Biogen announced that China’s National Medical Products Administration (NMPA) has approved Tecfidera (dimethyl fumarate) for the treatment of relapsing multiple sclerosis (MS). First introduced in 2013, Tecfidera has demonstrated a well-established safety and efficacy profile with more than 10 years of data from clinical trials and real-world experience. It has been used to treat more than 500,000 individuals with MS worldwide. The approval brings a new treatment option to people in China living with relapsing MS and also continues to expand the company’s presence in the country.

“It is truly a milestone to bring this well-established treatment to China and be able to help people living with relapsing multiple sclerosis,” said Rachid Izzar, president, Intercontinental Region at Biogen. “We thank the NMPA for undertaking priority review to approve Tecfidera. We are committed to expanding our presence in China and working with the MS community to address unmet medical needs through innovative therapies and solutions.”

The NMPA evaluation was based on data from the global, pivotal phase 3 DEFINE and CONFIRM studies, which enrolled more than 2,600 patients. In DEFINE, Tecfidera administered twice daily significantly reduced the annualized relapse rate by 53 percent (p<0.0001) compared to placebo, at two years. In CONFIRM, twice-daily Tecfidera significantly reduced the proportion of patients who relapsed by 34 percent (p=0.0020) compared to placebo at two years.

“MS is an inflammatory disease that attacks the central nervous system and, if not treated in a timely manner and following standard protocol, can lead to disability due to irreversible neurological damage. Currently in China, a small number of patients are treated according to the standard of care with a disease modifying therapy,” said Professor Yongjun Wang, deputy director of the National Clinical Research Center for Neurological Diseases, chairman of the Chinese Society of Neurology and president and chief physician of Beijing Tiantan Hospital, Capital Medical University. “The characteristics, clinical manifestation and disease course varies greatly among patients, which makes personalized treatment essential. Results from clinical trials and more than a decade of real-world evidence have demonstrated the efficacy, safety and tolerability of dimethyl fumarate. The approval and availability of dimethyl fumarate will provide a new option for patients and will help contribute to the clinical evidence on treating MS in China.”

The December 2020 General Social Survey on Patients with Multiple Sclerosis in China by the China Alliance for Rare Diseases found that among people with MS who are unemployed or out of school, 90 percent was due to their diagnosis. The report notes the need for the community to work together to help patients and families address the physical and mental challenges that can result from MS.

MS is a life-long, progressive, autoimmune neurologic disease of the central nervous system (CNS). In China, only approximately 10 percent of the population diagnosed with MS is being treated with a disease modifying treatment.2 It is the second most common cause of non-traumatic neurological disability in young adults.3 The disease causes damage to the CNS resulting in physical disability as well as neurological dysfunctions involving movement, vision and cognition. The severity and specific symptoms of MS vary from person to person. More than 85 percent of people with MS are diagnosed with relapsing MS, the most common form of the disease.

Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS) in adults, is the most prescribed oral medication for relapsing MS in the world and has been shown to reduce the rate of MS relapses, slow the progression of disability and impact the number of MS brain lesions, while demonstrating a well-characterized safety profile in people with relapsing forms of MS including clinically isolated syndrome, relapsing-remitting disease and active secondary disease.

Date: 20-Apr-2021

China NMPA Approves Biogens Tecfidera To Treat Multiple Sclerosis

Biogen announced that China’s National Medical Products Administration (NMPA) has approved Tecfidera (dimethyl fumarate) for the treatment of relapsing multiple sclerosis (MS). First introduced in 2013, Tecfidera has demonstrated a well-established safety and efficacy profile with more than 10 years of data from clinical trials and real-world experience. It has been used to treat more than 500,000 individuals with MS worldwide. The approval brings a new treatment option to people in China living with relapsing MS and also continues to expand the company’s presence in the country.

“It is truly a milestone to bring this well-established treatment to China and be able to help people living with relapsing multiple sclerosis,” said Rachid Izzar, president, Intercontinental Region at Biogen. “We thank the NMPA for undertaking priority review to approve Tecfidera. We are committed to expanding our presence in China and working with the MS community to address unmet medical needs through innovative therapies and solutions.”

The NMPA evaluation was based on data from the global, pivotal phase 3 DEFINE and CONFIRM studies, which enrolled more than 2,600 patients. In DEFINE, Tecfidera administered twice daily significantly reduced the annualized relapse rate by 53 percent (p<0.0001) compared to placebo, at two years. In CONFIRM, twice-daily Tecfidera significantly reduced the proportion of patients who relapsed by 34 percent (p=0.0020) compared to placebo at two years.

“MS is an inflammatory disease that attacks the central nervous system and, if not treated in a timely manner and following standard protocol, can lead to disability due to irreversible neurological damage. Currently in China, a small number of patients are treated according to the standard of care with a disease modifying therapy,” said Professor Yongjun Wang, deputy director of the National Clinical Research Center for Neurological Diseases, chairman of the Chinese Society of Neurology and president and chief physician of Beijing Tiantan Hospital, Capital Medical University. “The characteristics, clinical manifestation and disease course varies greatly among patients, which makes personalized treatment essential. Results from clinical trials and more than a decade of real-world evidence have demonstrated the efficacy, safety and tolerability of dimethyl fumarate. The approval and availability of dimethyl fumarate will provide a new option for patients and will help contribute to the clinical evidence on treating MS in China.”

The December 2020 General Social Survey on Patients with Multiple Sclerosis in China by the China Alliance for Rare Diseases found that among people with MS who are unemployed or out of school, 90 percent was due to their diagnosis. The report notes the need for the community to work together to help patients and families address the physical and mental challenges that can result from MS.

MS is a life-long, progressive, autoimmune neurologic disease of the central nervous system (CNS). In China, only approximately 10 percent of the population diagnosed with MS is being treated with a disease modifying treatment.2 It is the second most common cause of non-traumatic neurological disability in young adults.3 The disease causes damage to the CNS resulting in physical disability as well as neurological dysfunctions involving movement, vision and cognition. The severity and specific symptoms of MS vary from person to person. More than 85 percent of people with MS are diagnosed with relapsing MS, the most common form of the disease.

Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS) in adults, is the most prescribed oral medication for relapsing MS in the world and has been shown to reduce the rate of MS relapses, slow the progression of disability and impact the number of MS brain lesions, while demonstrating a well-characterized safety profile in people with relapsing forms of MS including clinically isolated syndrome, relapsing-remitting disease and active secondary disease.