The U.S. drug regulator said Thursday that only people with mild dementia should receive the first new Alzheimer’s disease drug in decades, after facing widespread backlash from the medical community over it. its authorization.
Biogen’s Aduhelm received “fast-track approval” by the Food and Drug Administration in June, despite a panel of independent experts advising the agency found insufficient evidence of its benefits.
“Since the agency approved Aduhelm, prescribers and other stakeholders have expressed confusion over the target population for treatment,” FDA spokesperson Michael Felberbaum said in a statement to the AFP.
“It was important to clarify the intent of the currently approved labeling for prescribers; in particular, that it is appropriate to initiate treatment in patients with mild cognitive impairment or mild stages of dementia in Alzheimer’s disease, ”he added.
The new label is consistent with the patient population studied in clinical trials.
While this does not prevent doctors from prescribing Aduhelm to patients in more advanced stages of the disease, it is a notable reversal.
Aduhelm, an intravenously infused monoclonal antibody, also known by its generic name aducanumab, has been tested in two advanced human trials, known as phase 3 trials.
It has convincingly shown a reduction in the build-up of a protein called beta-amyloid, which creates plaque in the brain tissue of patients with Alzheimer’s disease.
But it’s unclear whether this correlates with a reduction in cognitive decline – one study suggested it did, while the other did not.
As a result, many experts reacted with dismay to Aduhelm’s approval, and at least three of the 11 independent committee members who voted unanimously against the drug’s recommendation to the FDA subsequently resigned.
Beyond the false hope it could offer patients and their loved ones, Aduhelm’s sky-high price tag of $ 56,000 a year could cost Medicare, the federal insurance program for medical care, tens of billions of dollars a year. American seniors, experts argued.
“With Alzheimer’s disease affecting six million Americans, the financial and human implications of approval are staggering,” wrote Vinay Prasad, associate professor of medicine at the University of California at San Francisco, in an editorial in Medpage Today.
The Alzheimer’s Association responded positively to Thursday’s announcement.
“We appreciate the FDA’s thoughtful consideration and response to the Alzheimer’s Association and other members of the community, including physicians, researchers and patients, to ensure that this treatment is prescribed only to those who may benefit from it, ”the group said.
© 2021 AFP