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The last time an Alzheimer’s disease drug was approved by the FDA was in 2003. On Monday, a different new type of drug received “fast-track approval”, but it comes with a some controversy.
“It’s not your grandmother in a wheelchair, but it’s your grandmother in a wheelchair, but it’s also me,” said Pam Montana.
Pam started showing symptoms of mild cognitive impairment (MCI) around 2012. She was diagnosed with early Alzheimer’s disease four years later.
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She would be a good candidate for the new drug Aducanumab, which has just received “fast track” status from the Food and Drug Administration to slow the progression of the disease.
The human brain has millions of neurotransmitters that are constantly sending messages.
In Alzheimer’s disease, a protein called beta-amyloid plaques begins to clump together, blocking the brain’s ability to send these messages.
Biogen said the drug given once a month intravenously begins to dissolve these amyloids.
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“So the earlier you intervene, the better the chances that you can slow down these aspects,” said Maha Radhakrishnan, medical director of Biogen.
“So it’s different from the ones that came before that were temporarily helpful, but this one might actually save people more time,” said Elizabeth Edgerly of the Alzheimer’s Association Northern California.
But last year, an FDA advisory panel concluded that there was not enough evidence to support its effectiveness. Still, the FDA gave its approval, saying the benefits outweigh the risks.
Michael Carome of the consumer group, Public Citizens Health Research, said they were against his approval.
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“Approving this drug now, based on the fragile evidence available, would raise false hopes for millions of Alzheimer’s patients and their families,” Carome said.
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 this does it bring me, it brings more hope. “
Since Biogen has gained fast track approval, the company must now conduct further clinical studies while the drug is in use.
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