Charlotte doctor weighs in on FDA approval of first new Alzheimer’s drug since 2003
For the first time in nearly two decades, the U.S. Food and Drug Administration has approved a new drug for the treatment of Alzheimer’s disease. And one local specialist said dozens of Charlotte patients are already looking forward to the treatment’s arrival in North Carolina.
Novant Health’s Dr. Mark Pippenger, a neurologist who specializes in memory care, got at least 20 calls or messages from his patients on Monday after the treatment was approved by the FDA, he told reporters Tuesday.
The drug aducanumab, marketed under the name Aduhelm by the company Biogen, is the first new drug approved by the FDA to treat Alzheimer’s since 2003.
But some controversy has surrounded the FDA approval. Two studies of the drug were cut short, Pippenger said, though analysis of the studies shows there is significant reduction in amyloid beta plaque — a protein that collects in the brain tissue and is a hallmark of Alzheimer’s.
The FDA is requiring Biogen to conduct a new study to verify the benefits of the drug as a condition to approval. If the study fails, the FDA can withdraw approval.
Still, the introduction of a new treatment is a big deal, Pippenger said. “It’s the first time in 20 years we’ve had a drug to treat the disease,” he said. “That alone is exciting.”
But the drug is “far from a cure,” Pippenger cautioned.
The drug, a monthly infusion, is needed in high doses, and is likely only a viable treatment for people with extremely mild symptoms, Pippenger said.
And it will be extremely expensive. The yearly cost of the drug would be $56,000, Biogen announced Monday.
The Centers for Medicare & Medicaid Services have not yet announced coverage details for the new drug.
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