Atrium Health’s Response to New FDA-Approved Alzheimer’s Drug

06.17.2021 Atrium Health News

CHARLOTTE, N.C., June 17, 2021 – Clinical and research experts at Atrium Health are speaking out after a new, controversial Alzheimer’s drug, aducanumab (marketed as Aduhelm), was approved by the FDA on June 7. Its approval followed the review of information from two clinical trials.

Aducanumab is a monoclonal antibody that targets and removes amyloid, which is a protein in the brain associated with Alzheimer’s Disease (AD). There are many unanswered questions about the actions of amyloid and another protein called tau in AD.

“It was encouraging that the clinical trials did succeed in reducing the amount of amyloid in the brain, and this finding (rather than the clinical outcomes) was a major reason for FDA approval,” Dr. Steven Putman, consulting neurologist with Atrium Health Neurosciences Institute, said.

While amyloid was removed from the brain, only one of the two trials demonstrated statistical clinical improvement. Generally, two positive trials are required for approval. That’s why this drug’s release is controversial.

“Based on the data presented by Biogen to the FDA, aducanumab had a large impact on amyloid clearance but demonstrated only ‘reasonably likely’ positive effect on cognitive function,” said Dr. Oleg Tcheremissine, research director for Atrium Health’s Department of Psychiatry. “Consequently, both the short- and long-term implications of the FDA decision remain unclear.”

Currently, a good deal of work is ongoing identifying the best patient candidates for aducanumab through a benefit and harm review at Atrium Health. 

“Additional real world studies are necessary before aducanumab will be become the gold standard of treatment for AD,” Tcheremissine said.

Several leaders in the field of AD research have expressed strong disagreement in this drug’s release. Another point of contention is the price of this drug’s monthly infusion – approximately $56,000.

“Because aducanumab has been released and is the first drug to potentially slow the early stages of AD, we are now in the process of developing a safe and clinically sound protocol to select appropriate candidates to receive the drug,” Dr. Robert Mitchell, assistant specialty medical director for neurology at Atrium Health Neurosciences Institute, said. “We are also planning to participate in the phase 4 trial on this drug which was mandated by the FDA as a condition for its approval.”

A patient evaluation will require selective laboratory tests, brain imaging and cognitive evaluations to establish appropriate candidates for the treatment. Patient safety will be paramount as the program evolves. 

“One benefit is this new drug has opened the door for more research and generated hope for certain patient populations,” Mitchell said.

Further information regarding the use of aducanumab will be forthcoming in the next weeks.