Aduhelm is the first drug approved for Alzheimer’s since 2003, which has immediately become a controversy. While some call it a breakthrough, there are experts who consider the evidence is not good enough for the FDA approval. Aducanumab is its generic name which was granted accelerated approval. Alzheimer’s disease is often referred as a devastating condition, more for the elderly and geriatric patients. It leads to a condition known as dementia, which is among the top leading causes for death. Given the urgency of the situation, any breakthrough innovation that proves to be a better alternative is welcome. However, no quantum of urgency can be a justification for accelerated approvals when the data is not convincing enough. This certainly calls for a thorough review and a possible reversal of the approval, if the critics get their way with data and evidence.
Significance of accelerated drug approvals by the US FDA
As per the US FDA’s official website, FDA can authorize or approve a drug based on the surrogate or intermediate clinical endpoints, instead of waiting for the confirmatory trials. It may be understood as an interim approval which is usually granted based on the severity of the disease condition. Approvals of orphan drugs or drugs for orphan indications do fall under the similar category, with difference in specifications and terminology. Given the disease condition of Dementia caused due to Alzheimer’s, it is well justified for the innovator company to seek accelerated approval. It is also well within the scope of US FDA to grant such approvals. The status quo of the approvals do change based on the outcomes of confirmatory trails. The approval could either be cancelled or changed with new label information after reviewing confirmatory trials.
Specific objections to the US FDA approval of Aducanumab
Articles published in Science Magazine and National Geographic among the others have termed the accelerated approval for Aduhelm controversial. The point of contention is there is no clarity if the drug in question actually works. There are some reports that suggest that the FDA admits that the drug is not proven to the extent of saying it works for sure. Then what is the real benefit? It could be a very misleading approval that puts patients and caregivers under tremendous stress. Not to forget, it is a very expensive drug too. If the outcomes are not satisfactory, it is incumbent upon the accrediting agencies to seek more data and delay approvals till such data is available. It is not a new situation for FDA and therefore many experts are taken by surprise and chose to criticize Aducanumab approval as hasty and probably misguiding. It is wise for the FDA to reverse its approval, considering the criticism and backlash. There is also a lot of explaining to be done by the innovator company. But, the buck stops at the FDA for now to come clean with its stand and safeguard its reputation. May the science win!
