Summary List Placement
The arrival of the first new Alzheimer’s drug in two decades should have been a moment of celebration. But so far, the healthcare industry is feeling concerned.
On Monday, the US Food and Drug Administration approved a new medication called Aduhelm. The drug, made by the biotech company Biogen, is designed to remove a sticky plaque that builds up in the brains of some people with Alzheimer’s, which it did in clinical trials. But it isn’t clear that using the drug to clear this plaque leads to an improvement in memory and cognition.
“I don’t believe that the drug provides benefits,” Dr. David Knopman, a neurologist at the Mayo Clinic, told Insider. Knopman worked with Biogen on trials of the drug but was so opposed to its approval that he resigned as an FDA advisor this week. Two other FDA advisors have also stepped down.
Aduhelm, developed under the generic name aducanumab, actually failed in one late-stage clinical trial and was shelved in March 2019. It was revived later that year when an analysis found that a group of participants in a second trial had benefited from the drug.
Aduhelm will cost $56,000 a year
More than 6 million Americans have Alzheimer’s, according to the Alzheimer’s Association. Caring for them will cost $355 billion this year, including $239 billion in Medicare and Medicaid payments, the association found. A successful treatment would be a huge advancement for people with Alzheimer’s, but Knopman says Aduhelm falls short.
“The unmet need of the people with the disease is as great today as it was on Monday morning before the announcement,” Knopman said. “Aducanumab set a very low bar to exceed.”
The FDA said it approved Aduhelm because the potential benefits outweighed the drug’s risks. It’s requiring Biogen to run more trials to prove that the …read more