The first drug to treat Alzheimer's disease in nearly 20 years was approved by the FDA on Monday. Aducanumab is one of a long list of medications aimed to remove sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer's. This helps hold off the disease, which causes memory loss and destroys the ability to care for oneself. Clinical trials for the treatment, to be sold under the brand name Aduhelm - made by Biogen Inc - showed a reduction in the plaques which is expected to lead to a reduction in the clinical decline of patients. However, some critics dispute the drug's effectiveness and say the science of whether or not aducanumab actually works in shaky. The authorization of the drug comes via the U.S. Food and Drug Administration's (FDA) accelerated approval pathway, which provides earlier access for patients with diseases that have few therapies and where there is an expectation of benefit despite some uncertainty. Biogen still will have to run trials showing 'clinical benefit.' If the trials have negative results, the FDA can rescind its approval. Biogen launched two clinical trials for aducanumab in 2016, according to The Washington Post. Both were stopped midway because researchers concluded that neither would end up reaching its goal. But later, the company revealed updated data from the second study that showed patients had a 22 percent decrease in the speed of their cognitive decline. The company was hoping the data would be enough for the FDA to approve the drug because a third trial could take four to six more years to complete. In a statement, released Monday, Dr Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said the agency was aware of the controversy. 'We are well-aware of the attention surrounding this approval,' she wrote. 'We understand that Aduhelm has garnered the attention of the press, the Alzheimer's patient community, our elected officials, and other interested stakeholders.' 'With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review.' Advocates say that while the drug is not perfect, it can delay cognitive decline. An estimated six million Americans of all ages were living with Alzheimer's disease in 2018. Sufferers experience a decline in cognitive, behavioral and physical abilities, and there is no cure. Prior to Monday's approval, there were no drugs cleared by the FDA that can slow the mental decline from Alzheimer's, the sixth-leading cause of death in the U.S. Biogen has estimated that around 1.5 million Americans would be eligible for treatment with aducanumab, which is given by monthly infusion, raising concerns about costs to the healthcare system. The Alzheimer's Association is supportive of the drug, hoping that it can provide temporary help for patients, while also calling for further trials even after approval. 'We don't think this is the end all or be all,' Harry Johns, president and chief executive of the Alzheimer's Association, told The Post. 'It will take more advances, but it does appear from the science that people, especially at early stages, could be real beneficiaries and that the benefits accumulate over time.' Critics of the drug said approving the drug too early could hurt patients more than it would help, due to the wasted time and resources that may go into delivering a product that does not work. They also criticize Biogen's conclusion from the second trial, describing it as finding a conclusion then building the process to get there backwards in order to get the results they wanted. 'The worst thing for people with Alzheimer's would be to put out a product that doesn't work,' Aaron Kesselheim, a professor of medicine at Harvard Medical School, told the newspaper. 'It will be sold at an extremely high price and waste resources that could go to other things.' Source
