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| US regulators approve first Alzheimer’s drug that targets underlying cause of the disease | US regulators approve first Alzheimer’s drug that targets underlying cause of the disease |
| (3 months later) | |
| The US Food and Drug Administration (FDA) has approved Biogen’s new treatment for Alzheimer’s disease, making it the first medication given a green light that aims to target the underlying causes of the devastating illness. | The US Food and Drug Administration (FDA) has approved Biogen’s new treatment for Alzheimer’s disease, making it the first medication given a green light that aims to target the underlying causes of the devastating illness. |
| Called Aduhelm, the drug was approved by the FDA after clinical trials showed that the treatment successfully targets amyloid – the plaque that builds up in the brains of Alzheimer’s sufferers – helping to slow the onset of the illness. | Called Aduhelm, the drug was approved by the FDA after clinical trials showed that the treatment successfully targets amyloid – the plaque that builds up in the brains of Alzheimer’s sufferers – helping to slow the onset of the illness. |
| Developed by Biogen with Japan’s Eisai Co., the drug is the first treatment that directly targets the cause of the disease, using existing medicine, instead of helping to ease the symptoms of people afflicted with it. | Developed by Biogen with Japan’s Eisai Co., the drug is the first treatment that directly targets the cause of the disease, using existing medicine, instead of helping to ease the symptoms of people afflicted with it. |
| Discussing the FDA’s approval, Dr. Patrizia Cavazzoni, the director of the organization’s Center for Drug Evaluation and Research, described it as “a hallmark finding” that is “expected to lead to a reduction in the clinical decline of this devastating form of dementia”. | Discussing the FDA’s approval, Dr. Patrizia Cavazzoni, the director of the organization’s Center for Drug Evaluation and Research, described it as “a hallmark finding” that is “expected to lead to a reduction in the clinical decline of this devastating form of dementia”. |
| Despite the fanfare surrounding the approval, Dr. Ronald Petersen, an Alzheimer’s disease expert at the Mayo Clinic, warned that health officials “can’t overpromise” and need to be clear that “this is not a cure”. | Despite the fanfare surrounding the approval, Dr. Ronald Petersen, an Alzheimer’s disease expert at the Mayo Clinic, warned that health officials “can’t overpromise” and need to be clear that “this is not a cure”. |
| Biogen, alongside Eisai Co., had previously halted the development of the drug in March 2019, over concerns that the treatment wasn’t working. However, after reanalyzing the data, the companies reversed their decision, finding that patients in the early stages of the disease benefited from higher doses over a longer period of time. | Biogen, alongside Eisai Co., had previously halted the development of the drug in March 2019, over concerns that the treatment wasn’t working. However, after reanalyzing the data, the companies reversed their decision, finding that patients in the early stages of the disease benefited from higher doses over a longer period of time. |
| According to Biogen's estimates, following the FDA’s decision, some 1.5 million Americans will be eligible for the treatment, which is administered via a monthly infusion. The continued availability of the drug is contingent, however, on the success of post-approval trials to verify its clinical benefits among users. | According to Biogen's estimates, following the FDA’s decision, some 1.5 million Americans will be eligible for the treatment, which is administered via a monthly infusion. The continued availability of the drug is contingent, however, on the success of post-approval trials to verify its clinical benefits among users. |
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