Biogen and Eisai Submit Marketing Authorization Application for Aducanumab in Alzheimer's Disease to European Medicines Agency

Compiled by Keke

On October 30, Biogen and Eisai announced that the European Medicines Agency (EMA) had confirmed acceptance of the Marketing Authorization Application (MAA) for aducanumab, an investigational therapy for Alzheimer’s disease. Clinical data indicate that treatment with aducanumab can remove amyloid-beta protein and yield improved clinical outcomes. If approved, aducanumab would become the first treatment to reduce clinical functional decline in patients with Alzheimer’s disease and meaningfully alter the course of the disease.

Under the collaboration and license agreement, Biogen initially obtained the development license for aducanumab from NeurImmune. Since October 2017, Biogen and Eisai have been collaborating globally on the development and commercialization of aducanumab. Aducanumab (BIIB037) is an investigational human monoclonal antibody for the treatment of Alzheimer’s disease, targeting aggregated forms of beta-amyloid found in the brains of patients with Alzheimer’s disease, with the aim of reducing beta-amyloid accumulation.

After preliminary data from two Phase 3 trials indicated that the drug failed to meet its primary endpoints, Biogen halted its development in March 2019. On October 22 of the same year, Biogen announced that it would restart the U.S. FDA approval process for aducanumab, stating that a new analysis of a larger dataset showed that the drug could reduce clinical decline in patients with early Alzheimer’s disease when administered at higher doses.

The two pivotal, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 clinical trials, EMERGE and ENGAGE, which formed the basis for the marketing application of this drug, were designed to evaluate the efficacy and safety of aducanumab. The primary endpoint was to assess the efficacy of monthly doses of aducanumab versus placebo in reducing cognitive and functional impairment, as measured by the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. The secondary endpoints were to evaluate the effect of aducanumab versus placebo on clinical decline in patients, as measured by the Mini-Mental State Examination (MMSE), the Alzheimer’s Disease Assessment Scale–Cognitive Subscale 13-item (ADAS-Cog-13), and the Alzheimer’s Disease Cooperative Study–Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-ADL-MCI).

Clinical data indicate that aducanumab has the potential to modify the pathophysiology of the underlying disease, slow cognitive and functional decline, and help improve patients’ ability to perform activities of daily living, such as managing personal finances, performing household chores (including cleaning, shopping, and laundry), and traveling independently. In the EMERGE trial, patients receiving high-dose aducanumab exhibited a significantly reduced rate of clinical functional decline (23%) compared with placebo; however, the similar ENGAGE trial did not demonstrate a significant reduction, showing only a 2% slower rate of decline than the placebo group.

Even so, in August of this year, the FDA accepted the Biologics License Application (BLA) for aducanumab in the treatment of Alzheimer’s disease and granted it priority review, with a Prescription Drug User Fee Act (PDUFA) target date of March 7, 2021.

Reference Source:

1. Wikipedia

2.FDA ACCEPTS BIOGEN’S ADUCANUMAB BIOLOGICS LICENSE APPLICATION FOR ALZHEIMER'S DISEASE WITH PRIORITY REVIEW

3.European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer's Disease