It seems that the EMA (European Medicines Agency) had a clearer view of the problematic data of Aduhelm (Aducanumab). In July of 2021, the Food and Drugs Administration “FDA” made an exciting announcement as the first agent against Alzheimer’s disease (AD) was approved in more than 20 years. Despite the most confusing data reported in the ENGAGE and EMERGE trials, the true benefit of “Aducanumab” wasn’t clear to decrease the deterioration in patients suffering from Alzheimer’s disease.
From a medical standpoint, the agent was up-and-coming, an antibody that binds and inactivates the amyloid protein responsible of causing brain damage in AD patients. Basically, it means that the first drug against the proper biology of the disease was created. It makes sense to attack the very essence of the causing problem in a condition; nevertheless, the biological systems are far more complex than this. There are an incredible amount of factors that can modify its nature, and not always the most logical way to aboard a problem is an effective one. In this case, despite the promising mechanism of the drug, it did not translate into better clinical outcomes for AD patients. The data wasn’t clear from the beginning.
“Dementia care—it’s not rocket science, it’s heart science.”― Gail Weatherill, RN
The first red flag that I noticed is the published article wasn’t in a highly relevant medical journal, which raises the question of the validity of the data presented. Some of the more significant breakthroughs in medicine, speaking of drugs, are released in important journals so that physicians can have easy access to them. So for a groundbreaking agent, as “Aducanumab” claimed to be, it makes no sense to not be on this high-class journals. The second warning came from the FDA statistics committee, which failed to grant a clinical benefit to the drug. Still, despite it, the neurological committee gave a positive review of the medicine, claiming that it might be insufficient data regarding the lack of clinical results and the biological benefits of the drug might be better for selected early staged patients with AD. So against worldwide controversy and discussions, the drug was approved for its use in early-stage patients.
The EMA disagreed with the American agency, and after almost six months of extensive review, they gave a negative to Biogen’s new drug. But, surprisingly, the FDA didn’t follow its European counterpart immediately, and it took until yesterday to cancel the usage of the drug on Medicare and Medicaid services, questioning the data collected by both services in one year and also the reasons for the FDA to approve the drug with such lack of clinical evidence. Two after takes can be made of this particular case: 1.-Further analysis should be made regarding the authorized drugs by either the FDA or the EMA, even more when there are encounter opinions. 2.-The future of “Adulhelm” seems obscure, and future application of this drug appears to be done. We should observe the market for down retaliation on Biogen.
Despite the failure of this drug, there are some similar agents that we can be aware of, like Lilly’s “Donanemab,” which appears to have better clinical results. further evaluation of these agents needs to be made, but investment opportunities might be feasible.