New Alzheimer’s drug generates hope, controversy

The drug, intended to slow early progression, was authorized through a process that allows for rapid deployment.

Dave Yasvinski 4 minute read June 9, 2021

A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts, U.S., on Monday, June 7, 2021. Adam Glanzman/Bloomberg

The U.S. Food and Drug Administration has approved the use of an experimental drug for treatment of Alzheimer’s disease, despite fierce debate over whether or not the treatment actually works.

Aducanumab, also known as Aduhelm, is the first new Alzheimer’s treatment to be given the green light by regulators in almost 20 years, even though one of the FDA’s own committees was not convinced there was enough evidence to do so. The drug, intended to slow the early progression of the disease and its symptoms, was authorized under the agency’s accelerated approval program, a process that allows for rapid deployment of encouraging medication for life-threatening diseases — even if more study may be required. If post-approval studies do not confirm the clinical benefits of the drug, it could be pulled from store shelves.

“There has been considerable public debate on whether Aduhelm should be approved,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, according to CNN. “As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.

“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward. (The FDA) concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

Alzheimer’s disease, the most common cause of dementia, is a degenerative condition that is believed to be the result of the accumulation of certain proteins in the brain that leads to the slow death of neurons. This process eventually produces symptoms of memory loss, difficulty thinking or problem solving and changes in mood and behaviour.

There are over 500,000 Canadians living with dementia today  with another 25,000 diagnosed with the progressive disease every year, according to the Alzheimer Society. Two-thirds of those diagnosed over the age of 65 are women. With the rate at which the disease is growing, it costs over $12-billion a year to care for patients.

Late-stage trials of aducanumab were ended in March 2019 after an analysis showed it was no better at halting the deterioration of memory and cognition than a placebo in a pool of 3,000 patients. But an analysis by Biogen, the U.S. maker of the drug, concluded it was effective at slowing the speed of cognitive decline when administered in higher doses.

Late last year, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee was asked if it was reasonable to use evidence from a single study as the basis of aducanumab’s effectiveness. Ten members of the committee voted no and one was uncertain. There were no yes votes.

“In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion,” Cavazzoni said. “It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.”

The drug, which is administered intravenously once a month, is intended for use by patients with mild cognitive decline, not advanced dementia.

“We have to really temper expectations and explain to people that this drug is meant for the earliest symptomatic phases,” Richard Isaacson, the director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine in New York, told CNN. “It pains me to say this but if I have a severe Alzheimer’s patient that can no longer speak or interact much with others and their family member is begging me to give them this drug, I won’t be able to do it.”

Cost has also fuelled some of the controversy surrounding the drug, with each monthly infusion costing around US$4,300 — or over $50,000 per year for a high dose. Biogen said it is committed to ensure access to patients “across a spectrum of financial situations.”

Last month, the Institute for Clinical and Economic Review estimated that the drug should cost no more than US$8,300 annually, adding there is not enough evidence that the benefits of the drug outweigh the harms or helps reduce progression of the disease.

The Alzheimer’s Association, however, welcomed the news. “This approval is a victory for people living with Alzheimer’s and their families,” Harry Johns, the president and CEO of the group, wrote on Twitter.

Dave Yasvinski is a writer


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