The Food and Drug Administration (FDA) granted approval to a new Alzheimer’s treatment Monday that could prove to be the first drug to attack the debilitating disease at the source, rather than just treat its symptoms.
Aduhelm, Biogen’s new Alzheimer’s drug, is the first new treatment to be approved for the disease since 2003. It was approved by the FDA under the Accelerated Approval pathway, which allows therapies for serious conditions to be approved based on an “anticipated clinical benefit.”
The Accelerated Approval means that the FDA will require Biogen to conduct Phase 4 trials after the drug’s approval. Those Phase 4 trials must confirm that the anticipated clinical benefit actually takes place after the drug is used, and if those trials fail, the FDA could remove Aduhelm from the market.
Breaking news: The FDA has approved Aducanumab, the first FDA-approved drug that delays decline due to Alzheimer’s. On behalf of those impacted by Alzheimer’s & all other dementia, we celebrate today’s historic decision. pic.twitter.com/2oJIeMADog
— Alzheimer’s Association (@alzassociation) June 7, 2021
Approval of this new treatment has been the subject of intense debate among doctors, scientists, patients and advocacy groups due to the mixed results produced by Biogen’s trials. Two trials for Aduhelm were halted in March 2019 after independent monitors determined the drug was unlikely to benefit Alzheimer’s patients. (RELATED: EXCLUSIVE: Members Of Congress Make Bipartisan Call For Study Of Abusive FDA Animal Testing)
An additional analysis of those trials disagreed, determining that the drug could be beneficial, but FDA experts stated in November 2020 that they found the new analysis unconvincing, according to Stat News.
The drug is administered intravenously for one hour every four weeks and destroys beta-amyloid clumps in the brain. Biogen contends that destroying these clumps will slow cognitive decline, but there is no consensus among scientists on whether these protein clumps actually cause cognitive decline in Alzheimer’s patients, or if they are simply an effect.
The FDA said in a press release that “reduction in these plaques … is expected to lead to a reduction in the clinical decline of this devastating form of dementia.”
“In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” the agency added.