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US regulators have approved an Alzheimer’s drug from Biogen that split the scientific area, signaling an important moment for victims of the disease and their families. Aducanumab is designed for patients suffering from mild to moderate Alzheimer’s disease. Biogen asserts it reduces the progression of this disease by breaking up clumps of amyloid plaques that form in the brain. The treatment has been surrounded by controversy for years, and many scientists opposed its approval, saying it doesn’t work. The US Food and Drug Administration’s decision announced on Monday is monumental given that no new medication was approved for the disease in just two decades, and very few treatments exist. Nearly 6m people in the United States suffer from Alzheimer’s. The regulator confessed the contentious nature of its choice. “We’re well-aware of the focus surrounding this approval,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. She stated that the treatment was”fairly likely” to assist patients but included that doubt remained on the drug’s clinical benefit. Ultimately the agency concluded that the overall benefits of aducanumab outweighed its risks for Alzheimer’s patients. The FDA’s own panel of scientific advisors last year strongly opposed the approval of aducanumab, saying that Biogen’s trials did not demonstrate adequate evidence that the drug worked. Cavazzoni acknowledged the disagreements but said the medication removed amyloid plaques from the brain and”it is anticipated” this could reduce cognitive decline in people with the illness. The drug’s approval was fast-tracked because it fulfills an unmet demand for a serious disease and Biogen will need to carry out phase 4 trials. “This approval is a success for individuals living with Alzheimer’s and their families,” said Harry Johns, president of the Alzheimer’s Association. John Hardy, professor of neuroscience in University College London, said:”While I am pleased that aducanumab has obtained approval, we need to be clear that, at best, this is a drug with marginal advantage which can help just very carefully chosen patients.” Trading in Biogen’s stocks was halted ahead of the conclusion but shares in Western pharmaceutical firm Eisai, which it partnered with, surged 45 per cent. The FDA’s decision has consequences for research into Alzheimer’s past Biogen. Shares in Eli Lilly, which is presently trialling its amyloid-clearing drug, jumped 10 per cent.
