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Alzheimer's disease is a progressive neurological disorder that impairs thinking, memory and independence and leads to premature death.
the disease is a growing global health crisis affecting patients and their families.
tens of millions of people worldwide suffer from Alzheimer's disease, and that number will continue to grow in the coming years, according to the World Health Organization.
Aducanumab (BIIB037) is a β in-study monoclonal antibody that targets amyloid proteins.
yan Jian obtained the research and development license of aducanumab from Neurimmune.
has been developing and commercializing aducanumab globally since October 2017.
Aducanumab clinical development program includes two Phase 3 clinical trials, EMERGE and ENGAGE, in early Alzheimer's patients.
EMERGE clinical trial reached its primary clinical endpoint, with high-dose aducanumab significantly slowing down a cognitive ability score (CDR-SB) (22 percent, p-0.01) at 78 weeks compared to a placebo.
Aducanumab also reached a number of secondary endpoints in the EMERGE trial. in the
-YEAR and ENGAGE clinical trials, the red box showed that the amyloid plaque load in the low-dose and high-dose aducanumab groups was reduced at 26 and 78 weeks compared to the placebo (P.lt;001) for changes in CDR-SB scores in the high-dose group CDR-SB (Photo source: Ni jian official website) INED trial.
although the ENGAGE trial did not reach its primary endpoint, Yan Jian believes that some of its data support the clinical results observed in the EMERGE trial.
"Alzheimer's disease remains one of the greatest public health challenges of our time," said Michel Vounatsos, chief executive of Yanjian.
we look forward to fda reviewing our application.
" Reference: BIOGEN COMPLETES SUBMISSION OF BIOLOGIC LICENSE APPLICATION TO FDA FOR ADUCANUMAB AS A TREATMENT FOR ALZHEIMER'S DISEASE. Retrieved July 8, 2020, from original title: Treatment of Alzheimer's disease, Yan Jian submitted a listing application for amyloid antibody aducanumab
