Published: Apr 15, 2021
- TECFIDERA was approved under the National Medical Products Administration priority review process evaluating therapies with urgent clinical needs
- More than 500,000 individuals worldwide living with multiple sclerosis (MS) have been treated with TECFIDERA, which has a well-established safety and efficacy profile
- Biogen’s expansion in China now includes treatment options approved for relapsing MS and spinal muscular atrophy
CAMBRIDGE, Mass., April 15, 2021 (GLOBE NEWSWIRE) —Biogen Inc. (Nasdaq: BIIB) today 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.1 It has been used to treat more than 500,000 individuals with MS worldwide.1 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.
Click HERE to Subscribe for the MS Beacon eNewsletter
“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.
|
