Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for Aducanumab BLA

January 30, 2021/Bio ValleyBIOON/-- Biogen and its partner Eisai recently jointly announced that the U.S. Food and Drug Administration (FDA) has beenMonoclonal Antibody DrugsThe review period for the Biologics License Application (BLA) for aducanumab has been extended by three months. Aducanumab is an investigational drug for the treatment of Alzheimer’s disease (AD), with the latest Prescription Drug User Fee Act (PDUFA) target date set for June 7, 2021.

As part of the ongoing review, Biogen submitted its response to the FDA’s information request, including additional analyses and clinical data,FDAThis is considered a major amendment to the BLA, requiring additional review time.

Biogen CEO Michel Vounatsos stated, “We are committed to working with the FDA to complete the review of aducanumab. We would like to thankFDA“Continued efforts during the review period.”

Biogen submitted the BLA for aducanumab to the FDA in July 2020.FDAThe BLA was accepted in August 2020 and granted priority review. Currently, aducanumab is also under review by regulatory authorities in the European Union and Japan.

Alzheimer’s disease (AD) is one of the greatest public health challenges today, progressively impairing patients’ memory and ability to live independently, ultimately depriving them of basic functional capabilities.

Aducanumab is the first biologic agent targeting AD-related clinical symptom decline and pathological mechanisms to be submitted for regulatory approval. This drug is an antibody targeting β-amyloid (Aβ), inClinical Trialhas been shown to remove Aβ from the brain and significantly slow mild cognitive impairment (MCI) caused by AD and mild AD dementia.

Based on clinical data from patients with Alzheimer’s disease (AD) and mild cognitive impairment due to mild AD,Aducanumab has the potential to impact the underlying disease pathophysiology, slow cognitive and functional decline, and benefit patients’ ability to perform activities of daily living, including managing personal finances, performing household chores such as cleaning, shopping, and doing laundry, as well as traveling independently.

If approved, aducanumab will become the first therapy with the potential to meaningfully alter the course of Alzheimer’s disease (AD) and slow clinical decline in AD patients, and it will also be the first treatment to demonstrate that Aβ removal can lead to improved clinical outcomes.Pharmaceutical market research firm Evaluate Vantage recently released a report predicting that, if successfully launched, aducanumab will achieve global sales of $4.8 billion in 2026.

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Alzheimer’s disease (AD) is a progressive neurological disorder that impairs thinking, memory, and independence, leading to premature death. Currently, there are no means to stop, delay, or prevent the disease, which constitutes an increasingly severe global health crisis. According to the World Health Organization (WHO), tens of millions of people worldwide are living with AD, and this number is projected to continue rising in the coming years. The hallmark of the disease is pathological changes in the brain, including the abnormal accumulation of toxic amyloid-beta plaques, a process that begins approximately 20 years before the onset of clinical symptoms. Mild cognitive impairment caused by AD represents one of the early stages of the disease, during which symptoms become more apparent and detectable.DiagnosisCurrent research efforts are focused on the early detection and treatment of patients to maximize the slowing or halting of Alzheimer's disease (AD) progression.

The clinical development program for aducanumab included two Phase III trials (EMERGE and ENGAGE), which were conducted in patients with early Alzheimer’s disease (AD). The enrolled patients had mild cognitive impairment (MCI) due to AD or mild AD dementia, with Mini-Mental State Examination (MMSE) scores ranging from 24 to 30. In the EMERGE study, patients treated with aducanumab showed a significant slowing of decline in cognition and function (such as memory, orientation, and language), as well as a significant slowing of decline in activities of daily living, including managing personal finances, performing household chores (such as cleaning, shopping, and laundry), and traveling independently.

The EMERGE study (n=1,638) met its prespecified primary endpoint, with patients receiving high-dose aducanumab showing a significant reduction in the Clinical Dementia Rating–Sum of Boxes (CDR-SB) score from baseline at Week 78 (22% improvement versus placebo, p=0.01). In the EMERGE study, patients treated with high-dose aducanumab also demonstrated a sustained reduction in clinical decline as measured by prespecified secondary endpoints: Mini-Mental State Examination (MMSE; 18% improvement versus placebo, p=0.05), Alzheimer’s Disease Assessment Scale–Cognitive Subscale 13-item (ADAS-Cog 13; 27% improvement versus placebo, p=0.01), and Alzheimer’s Disease Cooperative Study–Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-ADL-MCI; 40% improvement versus placebo, p=0.001). Amyloid plaque imaging in the EMERGE study showed that both low-dose and high-dose aducanumab reduced amyloid plaque burden at Weeks 26 and 78 compared with placebo (p<0.001). Although the ENGAGE study (n=1,647) did not meet its primary endpoint, Biogen believes that a subset of data from the ENGAGE study supports the results of the EMERGE study.

The aducanumab clinical program also included the Phase Ib PRIME study and its long-term extension (LTE) in patients with early Alzheimer’s disease (AD), enrolling individuals with prodromal AD or mild AD dementia (Mini-Mental State Examination [MMSE] scores of 20–30). The results demonstrated that aducanumab reduced amyloid-beta plaques in a dose- and time-dependent manner. Analysis of exploratory clinical endpoints showed a slowing of clinical decline (as measured by the Clinical Dementia Rating–Sum of Boxes [CDR-SB] and MMSE; the 10 mg/kg dose achieved nominal statistical significance at Month 12), with effects sustained through 48 months in the LTE. (Bioon.com)

Original Source: BIOGEN AND EISAI ANNOUNCEFDA’S 3-MONTH EXTENSION OF REVIEW PERIOD FOR THE BIOLOGICS LICENSE appLICATION FOR ADUCANUMAB