Biogen Inc., a pharmaceutical company, recently developed a drug to combat Alzheimer’s by the name of aducanumab. As of Nov. 6, the FDA advisory committee voted against aducanumab because of it being controversial.
The biologics license application filing for aducanumab included data from the ENGAGE and EMERGE studies of the drug. ENGAGE and EMERGE studies are randomized, double-blind, placebo-controlled, parallel- group studies.
The Peripheral and Central Nervous System Drug Advisory committee voted 8 to 1 with 2 uncertain that the data from the EMERGE study does not provide strong enough evidence to support the efficacy for treating Alzheimer’s.
Alzheimer’s is a fatal condition, mostly known for the memory decline that comes with it. The disease causes brain cells to deteriorate and is the most common cause of dementia.
Eventually, a person with Alzheimer’s may forget how to perform basic tasks, such as dressing and bathing themselves. Alzheimer’s also causes changes in personality and behavior. These changes can include depression, mood swings, apathy, irritability and aggressiveness, distrust in others and delusions. Eventually, complications from severe loss of brain function—such as dehydration, malnutrition or infection—result in death.
In March 2019, Biogen Inc. announced the discontinuation of ENGAGE and EMERGE studies because they were unlikely to meet their primary endpoints. In October 2019, Biogen Inc. pursued regulatory approval of aducanumab based on positive results of a new analysis of a larger data set, which became available after the discontinuation of the ENGAGE and EMERGE studies.
In the new analysis, it was revealed that the EMERGE study met the primary endpoint, showing that patients treated with a high dose of aducanumab (10 mg/kg) experienced a statistically significant reduction in the clinical decline of Alzheimer’s. The ENGAGE study did not meet the primary endpoint.
On Nov. 4, the FDA published briefing documents for the advisory committee meeting, which appeared to be a positive reflection of aducanumab. However, the committee vote contradicts these documents. In August, the FDA granted priority review to Biogen’s BLA filing of aducanumab. The FDA’s final decision on aducanumab is expected on March 7, 2021.
Members of the FDA advisory committee said that the trial they were asked to evaluate was not finished. Even though the data appeared positive, the advisers could not know for sure.
“There’s a huge danger in approving something that is not effective,” said committee member Joel Perlmutter, an adviser and neurology professor at Washington University School of Medicine, at a recent committee meeting.
Not much progress has been made in treating or curing Alzheimer’s. The drugs that are currently available just treat the symptoms of the disease. If aducanumab gets approved, it will be the first medicine to help in the treatment of the actual disease and not just the symptoms.
Aducanumab, if approved, will also be the first medicine to show that removing amyloid beta (plaque in the brain) results in better clinical outcomes in Alzheimer’s patients. For now, all eyes will be on the FDA until their decision about aducanumab in March 2021.
Graphic by Katelyn Miller
