EU Rejects Approval for Alzheimer's Drug Leqembi, Battering Stock of Developer Biogen

Alzheimer's disease, this profound neurodegenerative disease, undoubtedly casts a heavy shadow over the patients and their families. In recent years, the elites of the pharmaceutical industry have spared no effort to devote themselves to the research and development of new treatments in the hope of bringing light to patients. However, a piece of news recently came, but like a dark cloud covering the sun, it is very frustrating.

On July 26, 2023, the European Medicines Agency (EMA) officially issued a statement to give negative feedback on the marketing application of Leqembi (Lecanemab), a new drug for Alzheimer's disease jointly developed by Isai and Biogen. After deliberation, EMA's Medicines Review Committee noted that although Leqembi showed slight signs of efficacy in clinical trials, the potential for significant side effects was too strong to ignore. Specifically, the new drug may cause serious complications such as brain swelling and bleeding, and some patients even need to be hospitalized. It is particularly alarming that the patient population carrying the APOE4 gene is at significantly increased risk of these adverse reactions.

EMA's decision undoubtedly poured cold water on the market, which had high hopes. After the news, Biogen's share price plummeted, falling more than 7%, which is a sign of the strong market reaction. In the face of this setback, the two pharmaceutical giants of Isai and Biogen quickly said that they will actively cooperate with the EMA and other regulatory agencies to jointly seek the possibility of Leqembi's re-examination of the listing application in the EU region.

It is worth noting that despite the setbacks in Europe, Leqembi has been approved by the FDA in the United States. At the same time, two other new Alzheimer's drugs, Aduhelm and Donanemab, are in the process of being approved around the world, and their fate is also affecting the pharmaceutical industry. The future direction of these three new drugs will undoubtedly become the focus of attention in the global medical field.

We know that the treatment of Alzheimer's disease is still a long and challenging road. However, we firmly believe that with the continuous efforts of scientists, more safe and effective therapies will emerge in the future, bringing good news to the majority of patients. Let's look forward to that day.