Alzheimer's (AD) overweight pounds! Yan Jian/Weiwood beta amyloid antibody aducanumab by the U.S. FDA priority review, accelerated approval!

!--ewebeditor:page title"--August 08, 2020 // -- Biogen and partner Eisai have jointly announced that the U.S. Food and Drug Administration (FDA) has accepted a license application (BLA) for the treatment of Alzheimer's disease (AD).
FDA has granted BLA priority review, with the Prescription Drug User Charges Act (PDUFA) target dated March 7, 2021.
FDA said it plans to review the application as soon as possible under the accelerated review process.
If approved, aducanumab will be the first treatment that has the potential to meaningfully change the AD process and slow the decline of AD clinical conditions, and the first to demonstrate that removing beta amyloid (A beta) can achieve better clinical outcomes."
AD is one of today's biggest public health challenges, resulting in patients gradually losing their memory and ability to live independently, ultimately depriving them of basic behavior.
aducanumab is the first biologic to submit BLA to the FDA for AD-related clinical symptomatic decline and pathological mechanisms.
, in early July this year, Yan Jian and Wei material completed the submission of the BLA of aducanumab to the FDA.
is based on on ongoing cooperation between the two parties and the FDA, and the application includes clinical data for Phase III EMERGE andENGAGE studies, as well as Phase 11 PRIME studies.
addition to the United States, the two sides are continuing to engage in dialogue with regulators in Europe and Japan in an effort to achieve the goal of filing applications in these markets.
did not use its Priority Review Voucher (PRV) for aducanumab BLA.
fda also said it was planning to hold an advisory committee meeting on the application at an as-yet-undecided date.
Vounatsos, CHIEF Executive Officer, said, "The FDA's acceptance of the aducanumab BLA and its priority review is an important step that promises to lead to a treatment that can meaningfully change the course of AD's disease."
look forward to working with the FDA throughout the review process and thank the thousands of clinicians, patients and caregivers who participated in our clinical trials and accompanied us through this journey.
believe that aducanumab marks the beginning of a new era of potential treatment for AD, which will inspire more discovery and innovation and give hope to those affected by this devastating disease. dr. Haruo Naito, chief executive of
, said, "The ability to reduce clinical decline and maintain as long an independent life as possible for a potential treatment drug is a priority for AD patients and their families.
if aducanumab is approved, we hope it will change the lives of AD patients.
we believe this historic milestone is an important step towards a shift in the treatment model for Alzheimer's disease, a public health issue for the elderly.
" is a progressive neurological disease that impairs thinking, memory and independence and leads to premature death, a growing global health crisis that cannot be prevented, delayed or prevented.
that according to the World Health Organization (WHO), tens of millions of people worldwide suffer from AD, a number that will continue to grow in the coming years.
the disease is characterized by changes in the brain, including abnormal build-up of toxic amyloid beta plaques, which begin about 20 years before the patient develops symptoms.
cognitive impairment caused by AD is one of the early stages of the disease, when symptoms begin to become more pronounced and can be detected and diagnosed.
current research focuses on identifying and treating patients as early as possible to minimize or stop the progression of AD. The
aducanumab clinical development project includes two Phase III trials (EMERGE andENGAGE) in early AD patients with mild cognitive impairment (MCI) due to AD and mild AD dementia (minimum mental state test MMSE score of 24-30).
In the EMERGE study, patients treated with aducanumab experienced a significant slowdown in cognitive and functional decline in cognitive and functional (such as memory, position, and language), as well as in daily activities, including dealing with personal finances, doing housework (such as cleaning, shopping and laundry), and traveling independently.
EMERGE (n-1638) study reached its pre-specified primary endpoint, with patients treated with high doses of aducanumab scoring significantly lower than baseline levels in clinical dementia scores (CDR-SB) at week 78 (22% better than placebo, p.01).
In the EMERGE study, patients treated with high doses of aducanumab also showed a sustained decrease in clinical decline measured by pre-specified secondary endpoints: improved mental state examination (MMSE; 18% improvement compared to placebo, p.05), Alzheimer's disease assessment scale cognitive sub-scale 1 3 (ADAS Cog 13; 27% improvement compared to placebo, p.01), Alzheimer's Daily Activity Scale Mild Cognitive Impairment Edition (ADCS-ADL-MCI; 40% improvement compared to placebo, p.001).
EMERGE study, amyloid plaque deposition imaging showed that low-dose and high-dose aducanumab reduced amyloid plaque load (p.001) at weeks 26 and 78 compared to placebos.
that although ENGAGE (n-1647) did not reach the main endpoint, Yan Jian believes that some of the data from the ENGAGE study support the results of the EMERGE study.
aducanumab clinical program also includes the Ib-phase PRIME study and its long-term extended study (LTE) for early AD patients, with a pre-driveN AD or mild AD dementia (MMSE score of 20-30).
The results of this study showed that aducanumab reduced amyloid beta plaques in dose and time-dependent ways, and analysis of exploratory clinical endpoints showed a slowdown in clinical decline (CDR-SB and MMSE, 10mg/kg doses were nominally statistically significant at 12 months) and continued in LTE for up to 48 months.
() !--/ewebeditor:page--!--ewebeditor:page title"--source: FDA Accepts Biogen's Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review !--/ewebeditor:page.