On Friday, the pharmaceutical company Biogen announced the Food and Drug Administration accepted its request to conduct a priority review of its experimental Alzheimer’s drug for approval. The faster-than-normal process sets the stage for treatment, called aducanumab, to be the first newly approved drug for the incurable, degenerative condition in nearly two decades. But there are many questions about whether aducanumab has enough evidence for its effectiveness.
Aducanumab is a lab-produced antibody designed to target amyloid, a protein found in the brain. In those with Alzheimer’s disease, sticky lumps of amyloid called plaque form and accumulate in the brain. Amyloid has long been thought to play a leading role in causing the brain damage characteristic of Alzheimer’s, so many scientists have theorized that drugs capable of destroying plaque can further destroy the brain. delay or prevent.
However, in March 2019, Biogen and its Japanese partner Eisai are both exposed their Phase III clinical trials of aducanumab, after an independent review found that the medication was probably not at the primary goal of the tears to lower the cognitive impairment in people who believe mild Alzheimer’s.
At the time, aducanumab was seen as the latest failure for the once-promised line of anti-plaque drugs that had reached clinical trials. This lack of success has begun convince scientists Elsewhere, look for potential treatments, such as drugs that interact with tau, another protein in the brain that is formed into clots called tangles in Alzheimer’s patients.
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In October 2019, however, Biogen made a surprising announcement. They had looked at their trial data (including results collected after the analysis that led to the completion of the trial) and concluded that there was in fact data from the first trial that showed that the drug would have met the aim to significantly slow down the cognitive decline of volunteers, compared to a placebo. The company also said it was hoping for data from a subset of patients in the second trial that gave a high dose of the medication, although the trial generally did not show a clinically significant result yet. In doing so, the company announced that it plans to submit the drug for review by the FDA.
This new development means that the FDA will conduct a priority review of the drug for approval. The agency must make a decision by March 7, 2021, although it may come sooner rather than later. If the drug was approved, it would be the first new approved drug for Alzheimer’s to come up in about 17 years, and probably the first intended to slow or prevent the worsening of the condition. The five currently approved treatments for Alzheimer’s treat only its symptoms.
However, outside scientists and experts have been skeptical about the evidence for aducanumab, even after the company released some of its newer data last December. And some have asked me loudly as the company simply spins the data favorably to save a failed drug.
The next step of the process may provide some clarity to those questions. Before the FDA approves an approval, it convenes a panel of independent experts in related fields to review the evidence itself and make a recommendation. Although the recommendations are not binding, the FDA rarely disagrees with them. Time will soon tell if aducanumab will pass pattern there.
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