The FDA approved changing the drug’s label to clarify that the treatment is intended specifically for patients with mild cognitive impairment or milder stages of disease, according to an announcement Thursday from the companies Biogen and Eisai.
“Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied,” the new prescribing information
Initially, the previous prescribing information for the drug — which was approved by the FDA last month — noted that aducanumab is indicated to treat Alzheimer’s disease but did not specify a certain stage of the disease.
“Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval. We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option,” Dr. Alfred Sandrock, Jr., head of research and development at Biogen, said in the company’s announcement.
In June, the FDA approved aducanumab
using its “accelerated approval
” program, which allows for the earlier approval of a drug for a serious or life-threatening illness even though more study into the drug’s benefits may be needed.
The FDA came under fire for approving the drug because the agency’s Peripheral and Central Nervous System Drugs Advisory Committee concluded last year that there was not enough evidence
to support the effectiveness of the treatment.
Several members of the advisory committee resigned in protest
after the FDA’s approval.
Under accelerated approval, aducanumab will still be studied as part of a Phase 4 confirmatory trial to verify its clinical benefit. If the trial does not verify the drug’s benefit, then the FDA could remove the drug from the market.