Clinical Study Discussion on Aducanumab (Aduhelm®): The Most Controversial Drug License Application in Century

EffPha’s President and CEO, Dr. Frank Shen was invited by Translational Medicine Division under the Biomedical Translation Research Center (BioTReC) of Academia Sinica to give a speech on Apr 18, 2023 with the topic of Clinical Study Discussion on Aducanumab (Aduhelm®): The Most Controversial Drug License Application in Century, discussing the clinical data of Alzheimer's drug Aducanumab (Aduhelm®), and the considerations and review results of the US FDA. With his extensive industry experience, he led the audience to understand the drug development process and controversial approval of the new drug.

Dr. Frank Shen introduced the concept of clinical trial design through the three clinical trials of Aduhelm®, including PRIME, EMERGE, and ENGAGE, which were released by the US FDA, and explained the trial results and the controversies in the drug license application process.

During the review process of Biologics License Application (BLA) for Aduhelm®, the US FDA advisory committees voted 10-0 to deny the drug license application, but the FDA ultimately granted the drug conditional approval. On the other hand, the European Medicines Agency (EMA) rejected the drug license application. After the controversial review process of its drug license application, the drug finally obtained marketing authorization in the US, which however caused that few doctors are willing to prescribe Aduhelm® after its launch due to the controversial review process.

This speech has attracted many experts who are concerned about the development of new drugs and clinical trials to join, and was completely full. Through the case of Aducanumab’s drug license application, Dr. Frank Shen discussed the review standards of health authorities for drug license application and the key considerations in the decision-making process of clinical study and practice, which triggered extensive discussions among the audience.