The review period of aducanumab, β protein antibody aducanumab, was extended by the FDA for 3 months

Biogen and partner Eisai recently jointly announced that the U.S. Food and Drug Administration (FDA) has extended the review period of the single-drug aducanumab biological product licensing application (BLA) by three months.
aducanumab is a research drug for Alzheimer's disease (AD), and the latest Prescription Drug User Charge Act (PDUFA) targets June 7, 2021.
as part of the ongoing review, Yan Jian submitted a response to the FDA's request for information, including additional analysis and clinical data, which the FDA considers a significant modification to the BLA that will require additional review time.
, Chief Executive Officer of the Company, said: "We are committed to working with the FDA to complete the review of aducanumab.
we would like to thank the FDA for its continued efforts during the review.
" submitted the aducanumab BLA to the FDA in July 2020.
FDA accepted the BLA in August 2020 and granted priority review.
, aducanumab is also under review by EU and Japanese regulators.
Alzheimer's disease (AD) is one of today's biggest public health challenges, which can lead to patients gradually losing their memory and ability to live independently, ultimately depriving them of basic behavioral abilities.
aducanumab is the first biologic agent to submit an application to regulators for AD-related clinical symptom decline and pathological mechanisms.
the drug is a target β amyloid protein (A beta) antibody that has been shown in clinical trials to remove A-beta from the brain and significantly reduce mild cognitive impairment (MCI) caused by AD and mild AD dementia.
Based on clinical data from patients with mild cognitive impairment caused by AD and mild AD, aducanumab has the potential to affect the pathophysiology of in-house diseases, slow cognitive and functional decline, and facilitate the patient's ability to carry out daily activities, including managing personal finances, doing household chores such as cleaning, shopping and washing clothes, and traveling independently.
if approved, aducanumab will be the first treatment with the potential to significantly alter the AD process and slow the decline of AD clinical conditions, as well as the first to demonstrate that the removal of A-beta can have better clinical results.
, a pharmaceutical market research organization, recently released a report predicting that if successful, aducanumab's global sales will reach $4.8 billion in 2026.
Alzheimer's disease (AD), a progressive neurological disease that impairs thinking, memory and independence and leads to premature death, is a growing global health crisis that cannot be prevented, delayed or prevented.
the World Health Organization (WHO), tens of millions of people worldwide suffer from AD, a number that will continue to grow over the next few years.
the disease is characterized by changes in the brain, including abnormal build-up of toxic amyloid β plaques, which begins about 20 years before the patient develops symptoms.
AD-induced cognitive impairment 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 early detection and treatment of patients to minimize or prevent AD progression.
aducanumab clinical development program includes two Phase III trials (EMERGE and ENGAGE) in early AD patients with mild cognitive impairment (MCI) due to AD and mild AD dementia (minimum mental state check MMSE score of 24-30).
In the EMERGE study, patients treated with aducanumab experienced a significant decline in cognitive and functional functions such as memory, aequenability, and language, as well as in daily life activities, including personal finances, household chores (such as cleaning, shopping, and laundry), and independent travel.
EMERGE (n-1638) study reached its pre-designated primary endpoint, and patients treated with high doses of aducanumab had a significantly lower clinical dementia score (CDR-SB) score at week 78 than the baseline level (22 percent improvement over 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: simple mental state testing (MMSE; 18% improvement over placebos), p-0.05), and Alzheimer's assessment scale cognitive subscale 1 3 (ADAS Cog 13; 27% improvement compared to placebo, p.01), Mild cognitive impairment version of the daily activity scale for Alzheimer's disease (ADCS-ADL-MCI; 40% improvement over placebo, p.001).
EMERGE study, amyloid plaque deposition imaging showed that low-dose and high-dose aducanumab reduced amyloid plaque load (p<0.001) at weeks 26 and 78 compared to placebo.
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.
clinical program also includes the IB Phase PRIME study and its Long-Term Extension Study (LTE) in early AD patients, who were treated with pre-AD or mild AD dementia (MMSE score 20-30).
The results of this study showed that aducanumab reduced amyloid β plaques in dose and time-dependent ways, and an analysis of exploratory clinical endpoints showed a slowdown in clinical decline (CDR-SB and MMSE, 10 mg/kg dose nominally statistically significant at the 12th month) that lasted 48 months in LTE.
original source: BIOGEN AND EISAI ANNOUNCE FDA'S 3-MONTH EXTENSION OF REVIEW PERIOD FOR THE BIOLOGICS LICENSE APPLICATION FOR ADUCANUMAB From Bio Valley, for more information please download Bio Valley APP (