The Food and Drug Administration (FDA) has changed who will qualify for a new Alzheimer’s drug, shrinking who is eligible from about six million people to somewhere between one and two million.
Aduhelm was approved by the FDA last month.
On Thursday, it was announced it will only be made available to those with mild symptoms because trial studies targeted that demographic.
Cheri Davies, whose husband Chris was diagnosed with younger-onset Alzheimer's several years ago, says she hopes the changes make patients feel more comfortable.
"Making that clarification shows that they’re paying attention to the study and to what doctors are saying, so I felt really hopeful that this will make it more impactful for the rest of the community, that there will be more trust in what is being put out there in a medication," says Davies.
The Alzheimer’s Association also agrees with the changes.
The organization’s chief science officer, Dr. Maria C. Carrillo, released a statement Thursday, saying this will help make sure people prescribed the drug will actually benefit from it.
Davies' husband has been recommended to take Aduhelm, but has not been able to do so yet because insurance providers continue to figure out costs.
"I don’t think that’s going to be far down the road, but again, the hope that it brings with it is just really what we’re hanging on to right now," says Davies.
While some are celebrating, controversy surrounding the drug continues.
Acting FDA Commissioner Dr. Janet Woodcock said Friday she is recommending an investigation into conversations between her agency and Biogen, which makes Aduhelm, prior to its authorization.
Woodcock says she is confident in the agency's practices, but acknowledges public concern.
Aduhelm is the first Alzheimer's-related drug to be approved by the FDA in almost two decades.
This means only about 1-2 million people will qualify for the drug. Original estimates hoped for six million.
— Jaclyn Cangro (@JaclynCangro) July 9, 2021
Still, the Alzheimer’s Association also says it agrees with the FDA’s decision, citing trial studies of Aduhelm that focused on those with mild symptoms. pic.twitter.com/FNqiQOY3NJ