Aducanumab is expected to be approved for listing in Europe for Alzheimer's disease

On October 30th, the two companies announced that the European Medicines Agency (EMA) had confirmed its acceptance of a market authorization application (MAA) for the Alzheimer's research drug aducanumab.
clinical data show that the use of aducanumab treatment can remove β protein and achieve better clinical results.
if approved, aducanumab would be the first treatment to reduce clinical decline in Alzheimer's patients and meaningfully change the course of Alzheimer's disease.
under a cooperative development and licensing agreement, Yan Jian initially obtained aducanumab research and development license from Neur Immunit.
since October 2017, Yanjian and Wessa Worldwide have been working together to develop and commercialize aducanumab.
Aducanumab (BIIB037) is a research human monoclonal antibody used to treat Alzheimer's disease, targeting the aggregation of β-amyloid protein found in the brains of Alzheimer's patients, with the aim of reducing the accumulation of β-amyloid protein.
stopped developing the drug in March 2019 after preliminary data from two Phase 3 trials showed the drug could not reach its primary endpoint.
On October 22nd of the same year, Yan Jian announced that it would restart the FDA's approval process for aducanumab, giving a new analysis of a larger data set that showed that the drug could reduce clinical decline in patients with early Alzheimer's disease when given higher doses.
two key multi-center, randomized, double-blind, placebo-controlled, parallel group Phase 3 clinical trials, EMERGE and ENGAGE, which determine the drug's application for market, were designed to assess the efficacy and safety of aducanumab.
endpoint of this study was to assess the efficacy of receiving monthly doses of aducanumab in reducing cognitive and functional impairment compared to placebos through changes in the total number of clinical dementia scoring boxes (CDR-SB). the
secondary endpoints are the assessment of the effects of aducanumab on clinical decline in patients compared to placebo by the Simple Mental State Check (MMSE), the Alzheimer's Assessment Scale Cognitive Subscale 13 (ADAS-Cog-13) and the Alzheimer's Disease Cooperative Study-Daily Activity Scale Light Cognitive Impairment Scale (ADCS-ADL-MCI).
According to clinical data, aducanumab has the potential to affect the pathophysiology of a patient's underlying diseases, slow cognitive and functional decline, and help improve the patient's daily life skills, such as managing personal finances, doing household chores (including cleaning, shopping and laundry), and traveling independently.
In the EMERGE trial, patients who received high doses of aducanumab had a significantly lower rate of clinical decline (23%)than placebos, but similar ENGAGE trials showed no significant decrease, even 2% slower than in the placebo group.
Even so, in August this year the FDA accepted aducanumab's Biological Products License Application (BLA) for the treatment of Alzheimer's disease and granted the BLA priority review, with a target date of March 7, 2021 for the Prescription Drug User Charge Act (PDUFA).
source: 1. Wikipedia 2. FDA ACCEPTS BIOGEN'S ADUCANUMAB BIOLOGICS LICENSE APPLICATION FOR ALZHEIMER'S DISEASE WITH PRIORITY REVIEW3. European Medicines Agency Accepts Biogen's Aducanumab Marketing Authorization Application for Alzheimer's Disease