The FDA authorized the first new Alzheimer’s medicine in almost two decades on Monday, despite resistance from the agency’s independent advisory group and several experts who argued there wasn’t enough evidence the treatment might genuinely assist patients.
FDA Approves Alzheimer’s Medicine Regardless Of Expert’s Opinions
According to the Alzheimer’s Association, aducanumab (Aduhelm) demonstrated a 22% reduction in the development of thinking and memory impairments linked with Alzheimer’s disease in clinical studies. The patient advocacy organization asked the FDA to approve the medicine, describing it as a medication that might make a significant impact in the lives of people living with Alzheimer’s disease and their families.
However, Monday’s approval contradicts the FDA’s own independent advisory committee’s near-unanimous advice against using the medicine, as well as the concerns of several notable Alzheimer’s experts.
Recognizing that clinical studies of the medicine provided insufficient and contradictory evidence of its efficacy, the FDA has permitted on the condition that medication producer Biogen perform a new clinical trial.
The need for medicines is urgent. More than 6 million Americans are already living with Alzheimer’s disease, and this figure is likely to rise as the population ages, according to the FDA in a statement. Although the facts on Aduhelm’s therapeutic advantages are difficult, the FDA has assessed that there is considerable evidence that Aduhelm decreases amyloid-beta plaques in the brain and that this decrease is fairly expected to predict significant benefits to patients.
The FDA will continue to watch Aduhelm as it makes its way to the market and, eventually, the patient’s bedside. In addition, the FDA has mandated that Biogen execute post-approval clinical research to validate the drug’s therapeutic benefit. They can take steps to withdraw the medicine off the market if it does not work as planned.
Back in November, ten of eleven members of an FDA advisory group voted against clearance, after hearing a presentation from the agency’s head of neuroscience saying that the medicine is supported by good data.
Three members of the advisory group went even farther, producing a comprehensive analysis of the evidence. According to The New York Times, they have been joined by a slew of additional experts, including those who took part in aducanumab’s clinical trials.
Dr. G. Caleb Alexander, an FDA advisory committee member with the Johns Hopkins Bloomberg School of Public Health, believes there is no path to approval because of the lack of evidence that has been shared to date that this product works, and he believes it will set a remarkably dangerous precedent, not only for the field of Alzheimer’s research but also for the country’s broader regulation of prescription drugs.
Nonetheless, proponents such as the Alzheimer’s Association herald the treatment as the first to directly address a suspected cause of the degenerative neurological illness, rather than merely its symptoms. It is the FDA’s first new Alzheimer’s medication approval since 2003.
According to Stephen Salloway, head of neurology and the Memory and Aging Program at Butler Hospital in Providence, R.I., this will provide a new biological footing on which to grow. They must have the finest in class to attain the best in the industry.
The intravenous medicine would be profitable for Biogen and may cost up to $50,000 per patient every year, according to the Post.
The drug’s development journey has been difficult. Biogen said in March 2019 that it was discontinuing two clinical trials of aducanumab since the treatment did not appear to be making a significant effect.
However, Biogen revised its judgment seven months later when further examination of data from one of the trials revealed that aducanumab showed some benefit at larger dosages, according to the Times.
With more than 6 million Americans living with Alzheimer’s, the Alzheimer’s Association stated in a statement that the need for therapy for a disease with no survivors has never been stronger.