By MARY KEKATOS ACTING U.S. HEALTH EDITOR and MANSUR SHAHEEN FOR DAILYMAIL.COM and ASSOCIATED PRESS
A Rhode Island man has become the first patient in the world to receive an infusion of a newly approved Alzheimer’s disease drug.
Marc Archambault, a 70-year-old real estate broker from South Kingstown, was treated at Butler Hospital with aducanumab, which was approved by the U.S. Food and Drug Administration (FDA) on June 7.
Aducanumab, which is sold under the brand name Aduhelm, works by removing the sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of the age-related brain disease.
Critics say clinical trial results were mixed, doubting the drug’s effectiveness and questioning if the approval process was too quick.
What’s more, three members of an FDA advisory committee resigned, saying they didn’t feel members were consulted before being authorization was given.
But Archambault says the drug may be his last chance at preventing his Alzheimer’s disease from progressing to a late stage, in which he would lose the ability to carry on a conversation or even control movement
Marc Archambault, a 70-year-old real estate broker from South Kingstown, Rhode Island, became the first patient to be injected with Aduhelm on Wednesday (above)
Aduhelm (aducanumab), which was developed by Biogen Inc, to treat Alzheimer’s disease, was approved by the FDA on June 7
‘I am a happy guy but hearing that the FDA had approved Aduhelm and that I am eligible for the treatment. I am living happier of course,’ Archambault said in a statement.
‘The thought that the last stage [of Alzheimer’s] may now be far away for me, or even that I might stay as I am, is incredible. I feel very lucky to have the opportunity to receive this treatment.’
Dr Stephen Salloway, who oversees the Memory and Aging Program at Butler, said around 100 patients will be given he drug once a month.
‘Today, we’re making history,’ he said at a press conference on Wednesday.
‘We’re opening a new era in the treatment of Alzheimer’s disease.’
The authorization of the drug comes via the FDA’s 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.
Advocates say that while the drug is not perfect, it can delay cognitive decline.
Archambault (left and right) will be one of 100 patients treated at Butler Hospital with the drug in hopes it will prevent their Alzheimer’s from reaching late stages. The drug removes amyloid beta proteins from the brain and could slow down patients’ cognitive decline
Critics argue that trial data from Biogen was conflicting and drug approval too early could hurt patients more than it will help. Pictured: A sign marks a Biogen facility in Cambridge, Massachusetts
Alzheimer’s disease is a progressive brain disorder that slowly destroys memory, thinking skills and the ability to perform simple tasks.
It is the cause of 60% to 70% of cases of dementia.
The majority of people with Alzheimer’s are age 65 and older
More than six million Americans have Alzheimer’s.
It is unknown what causes Alzheimer’s. Those who have the APOE gene are more likely to develop late-onset Alzheimer’s.
Signs and symptoms:
Stages of Alzheimer’s:
An estimated six million Americans of all ages are living with Alzheimer’s disease in 2021.
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.
But the drug’s controversial rollout also caused three few members of an FDA advisory board to step down from their positions
Neurologists David Knopman, who works for the Mayo Clinic, and Joel Perlmutter, of Washington University St Louis, both stepped down on June 9 and Arron Kesselheim, a Harvard University professor, on June 10.
Knopman, Kesselheim and Perlmutter were among the 10 of 11 members of the FDA advisory board that voted against the drug’s approval in November.
Recommendations from the board are not binding, though, and the FDA is allowed to, and often does, make decisions that go against the boards vote.
It is rare that a near unanimous decision by the board is ignored, though, and the agency is generally more conservative that experts on the board – which was not the case with aducanumab
‘[Aducanumab] probably the worst drug approval decision in recent U.S. history,’ Kesselheim wrote in a letter to FDA Commissioner Janet Woodcock on Thursday, per Stat News.
‘It is clear to me that FDA is not presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.’
What’s more, Biogen set an average price of $56,000 a year for the drug.
Despite the fact that most patients who use the drug will be covered by the federal Medicare health program, the Alzheimer’s Association said the cost ‘simply unacceptable.’
Robert Egge, chief public policy officer at the Alzheimer’s Association, said most Medicare recipients will be responsible for 20 percent of the cost of drugs given by doctors.
‘This could further exacerbate health equity challenges that we have across the country,’ he told Reuters.