Biogen/Eisai's Alzheimer's disease drug Aduhelm was rejected by the European Union!

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Everything is expected

Recently, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has formally given a negative opinion on the marketing authorization application of Biogen and its partner Eisai for the application of the monoclonal antibody drug Aduhelm for the treatment of early Alzheimer's disease (AD)

On Friday, Bojian said when disclosing the news that it would seek CHMP to re-examine the opinion

In rejecting Aduhelm, EMA pointed out some known conditions of the drug

In terms of supervision, the US FDA accelerated the approval of Aduhelm in June 2021 based on data clearing AD biomarkers

In its veto, EMA also pointed out that the results of two controversial Phase 3 trials (EMERGE and ENGAGE) appear to be conflicting

In addition, EMA has questioned the safety of Aduhelm, especially a dangerous side effect called Amyloid-Associated Imaging Abnormality (ARIA), which may manifest as cerebral hemorrhage or swelling

When talking about ARIA, EMA said: "It is not yet clear whether these abnormalities can be properly monitored and managed in clinical practice

In addition to Europe, Bojian and Eisai also filed Aduhelm's listing application in Japan, and the progress seems very optimistic

At the same time, Bojian now hopes to launch a post-marketing confirmatory clinical trial in May next year, and hopes to report data by 2026

Reference source: Biogen vows to contest EMA rejection of Aduhelm as EU regulators question weak link to Alzheimer's clinical benefit