After much criticism, the Food and Drug Administration has pulled back on its blanket approval of the drug Aducanumab — saying it should only be given to certain Alzheimer’s patients.
The move comes after the first patient received the pricey medication in Chicago.
The $56,000-a-year drug was approved by the FDA in June. Some celebrated the announcement and others criticized the decision.
“The mixed response goes back to study of this medication and the study included two legs of the trial, one of them showed some benefits and another one didn’t,” said Dr. Lenny Cohen.
But after taking a closer look at the study data, the drug’s maker, Biogen, resubmitted an application — citing a positive response in early-stage patients.
“We don’t like stuff like that as physicians because it’s kind of cherry-picking data,” Dr. Cohen said. “That being said, when you design studies it’s very difficult to predict what kind of outcome you can have. You like to think that you know everything, but you don’t.”
What Mahmood Mohtadi’s family knew was that the 86-year-old was slipping.
“It happened little by little, and then I noticed he does something, you know sitting long time, no talking, and kinda I thought, maybe he is depressed?” said wife Lili Mohtadi. “But then when we saw doctor and they said, yes, he’s going through Alzheimer’s.”
Family hopes Aducanumab, now branded as ADUHELM — an antibody designed to clear amyloid plaque, a substance that accumulates in the brain of Alzheimer’s patients, will help.
“Having medication that can potentially slow down significantly is a good thing for patients and their families,” Dr. Cohen said.
Mohtadi’s dose was provided by Biogen free-of-charge because doctors are waiting for an official code before they can bill for the drug.
“I would love to say that insurance must, but that is not true. Insurance should cover the cost of the drug considering there are no other options, considering the medication works in a very unique fashion, by destroying amyloid plaque. I predict that most insurances will have to cover it,” Dr. Cohen said.
When ADUHELM was given the green light, it was designated for all Alzheimer’s patients. Recently, the FDA clarified its position and said treatment should only be initiated for those with “mild cognitive impairment or mild dementia.”
Dr. Cohen agreed the drug should not be used in later-stage patients.
I truly believe, and data supports it, the only people who will benefit from that, those who are in early stages of dementia,” Dr. Cohen said. “Those who might not even have actual dementia yet, they have something we call mild cognitive impairment.”
Despite the controversy, for the Mohtadi family, the first of what will be monthly infusions is a step in the right direction. Aricept, the medication he’s been taking for six months, is a drug that is designed to improve nerve cell function in the brain — but has no impact on Amyloid build up.
“If I’m healthy, I have everything,” Mahmood Mohtadi said. “If I am not healthy, I have nothing.”
The dose of the drug increases every month until patients reach the highest levels. Biogen will have to keep submitting data as a condition of FDA approval
For patients facing difficulty affording ADUHELM, financial assistance programs are available that may help eligible patients. For more information, please contact Biogen Support Services at 1-833-425-9360.