Advocates say new Alzheimer's drug could give patients more time; critics say it gives false hope
The last time an Alzheimer's drug was approved by the FDA was in 2003. Monday, a new, different kind of drug has been given "accelerated approval," but it comes with some controversy.
"It's not your grandma in a wheelchair, but it is your grandma in a wheelchair, but it's also me," Pam Montana said.
Pam began showing symptoms of mild cognitive impairment (MCI) around 2012. She was diagnosed with early Alzheimer's four years later.
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She would be a good candidate for the new drug Aducanumab, which was just given "accelerated approval" status by the Food and Drug Administration to slow the progression of the disease.
The human brain has millions of neurotransmitters constantly sending messages.
In Alzheimer's, a protein called amyloid beta plaques begin to clump together, blocking the brain's ability to send those messages.
Biogen said the drug given once a month through an IV, begins to dissolve those amyloids.
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"So the earlier you intervene the better the chances that you are able to slow down those aspects," Maha Radhakrishnan, Biogen's Chief Medical Officer said.
"So it is different from the ones that came before that were temporarily helpful, but this one actually could potentially buy more time for people," said Elizabeth Edgerly of the Alzheimer's Association Northern California.
But last year, an FDA advisory committee concluded there is not enough evidence to support its effectiveness. Still, the FDA gave its approval, stating that the benefits outweigh the risks.
Michael Carome of the consumer group, Public Citizens Health Research, says they have been against its approval.
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"Approving this drug now, based upon the flimsy evidence available, would raise false hopes for millions of Alzheimer's patients and their families," Carome explained.
But people living with Alzheimer's, like Montana, say it's a start that will hopefully lead to more treatment options. She wants to be there for her seven grandchildren and the rest of the family.
"I really need more time," she said. "I need more time with them, I need more time with my children, I need more time with my husband, I need more time with my friends and that's what this brings to me, this brings more hope."
Because Biogen was given accelerated approval, the company now has to conduct new clinical studies while the drug is in use.
