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FDA approves new Alzheimer's drug
The U.S. Food and Drug Administration approved Aduhelm for the treatment of Alzheimer's on Monday, the first new medication for the diease in 18 years.
SAN FRANCISCO - The Food and Drug Administration approves the first new Alzheimer's drug in 18 years amidst a fierce debate over whether it works and UCSF at Mission Bay in San Francisco is among the testing sites for this new drug.
There is mixed reaction among those who have firsthand experience with the disease.
"She got lost. She had trouble playing cards," Paul Kameny said Monday as he held a photo of himself and his wife Carol got lost while they were on a cruise eight years ago, shortly before she was diagnosed with Alzheimer's.
"I just broke down and cried and then I got to work," says Kameny.
He got to work caring for his wife of 50 years.
On Monday, he heard about the latest treatment.
The FDA approved a new drug aducanumab.
It may be the first drug to slow the progression of the disease in people in the early stages.
He says Carol is in the mid- to late-stages of Alzheimer's, but that the drug gives hope.
"I can't get it to do more for Carol at this time. But when it can, I'll be very happy," he said.
"It's intravenous, once a month," says Dr. Peter Ljubenkov, a dementia specialist with UCSF's Memory and Aging Center at Mission Bay.
The drug has been given to patients participating in the clinical trials conducted there.
"It's certainly a paradigm shift for the field. I'm excited about that. We now have a disease modifying drug," says Dr. Ljubenkov.
But the FDA's approval Monday was controversial.
Potential side effects include brain inflammation and bleeding.
There are mixed results from the clinical trials and an independent panel of experts recommended against FDA approval.
"It's certainly is unusual to have FDA approval with one negative trial and one positive trial," says Dr. Ljubenkov.
.At the Institute on Aging, Monday marked the first day of in-person programs resuming since the pandemic shutdown.
Alison Moritz, program director for dementia services says so far, families of Alzheimer patients have expressed optimism, "They have said where do I sign up? How soon will I get this?"
"It's very exciting, but we have to wait, It's the only way we can be realistic right? says Kameny as he looks at his wife who nods in agreement.
Dr. Ljubenkov says it'll likely take a few months for the drug to be given to patients as a treatment.
Biogen, the maker of the drug, says it would charge $56,000 a year per patient, without insurance.