The Food and Drug Administration reversed course on its endorsement of Aduhelm, a drug it said could be used effectively to treat patients with all degrees of Alzheimer’s disease, reissuing instruction that it should only be administered to patients with mild memory or thinking problems.
The New York Times reports that the new guidance shrinks the pool of potential patients eligible for the drug from six million to about 1.5 million.
The initial, now-revoked FDA permission would’ve marked the first time a single drug was licensed to treat all Alzheimer’s patients regardless of the disease progress. It was also the first Alzheimer’s drug in 18 years to be approved. Aduhelm works differently than the previous treatments in that it works on the limiting the protein amyloid that builds up in the brain, thought to be the cause of Alzheimer’s.
The drug’s approval was one of the most contentious in recent history. Many scientists found scant evidence that Aduhelm was effective at reducing amyloid. Others questions the issuance of authority to give the drug to all stages of patients.
“The revision of this label is yet another piece of evidence that should cause the American public to be concerned about how F.D.A. is practicing its regulatory science,” said Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center.