Biotech company Biogenannouncedlast week it will stop selling Aduhelm, a controversial monoclonal antibody drug for Alzheimer’s disease. The drug will leave the market in November 2024.
Aduhelm, given as a monthly IV infusion, receivedaccelerated approvalfrom the Food and Drug Administration (FDA) just three years ago to treat people with mild cognitive impairment or early Alzheimer’s disease. Data suggested it could possibly slow cognitive decline slightly, but it couldn’t cure Alzheimer’s.
Accelerated approval is given to drugs for conditions that have “unmet needs” when research can show effectiveness on a “surrogate endpoint” rather than definitely prove the drug is effective. In the case of Aduhelm, Biogen showed that the drug could reduce beta-amyloid plaque, aprotein in the brain linked to Alzheimer’s.
Accelerated approval requires a post-approval clinical trial to prove effectiveness, which Biogen is also ending.
Experts challengedAduhelm’s effectiveness, practicality, and safety before and after its approval, especially because of the risk of brain swellingand the $28,000 annual price tag.Still, removal from the market will be a blow to patients and their families who found the drug helped their cognitive symptoms.
Why Is Aduhelm Being Discontinued?
While Aduhelm’s approval was controversial—of two studies Biogen submitted to the FDA, one showed no benefit, and the other showed only slight benefit in slowing cognitive decline—the decision to discontinue the drug came down to low sales,Anastasiya Shor, PharmD, director of the Drug Information Center at Touro College of Pharmacy in New York, told Verywell.
“There are a lot of possible reasons for why this drug has not taken off, including but not limited to lack of efficacy, questionable study analyses, [and] the burden of frequent monitoring visits associated with brain swelling and brain bleeds,” Shor said.
In order to receive Medicare reimbursement for Aduhelm, patients wererequired to be part of a clinical trial, which can be arduous for them and their caregivers. That, paired with the drug’s high list price and the cost of regular imaging to check for adverse effects on the brain, limited the medication’s practical value.
What’s Next for Alzheimer’s Patients?
Biogen will continue to support a different Alzheimer’s medication, called Leqembi, that it manufactures with pharmaceutical company Eisai.
Leqembi is a monoclonal antibody requiring twice-a-month infusions, though an injectable version is in the works. Just like Aduhelm, Leqembi is indicated for patients with mild cognitive impairment or early stages of Alzheimer’s disease.
But Leqembi may be only minimally safer and more effective than Aduhelm.
“Leqembi showed a lower rate of brain abnormalities on PET scans when compared with Aduhelm, but we do not have head-to-head studies about this,” Shor said. “It appears Biogen decided to focus their efforts on Leqembi rather than split the focus and resources between the two drugs.”
Leqembi was originally grantedaccelerated approvallast yearbut received full FDA approvala few months later. Full approval means Medicare will cover the drug for appropriate patients without the need to be enrolled in a clinical trial.
What To Know About Leqembi, the New Alzheimer’s Disease Treatment
Patients who are no longer able to get Aduhelm won’t necessarily be automatically switched to Leqembi, said Marc L. Gordon, MD, chief of neurology at Zucker Hillside Hospital in Glen Oaks, New York.
“That’s got to be a decision made in conjunction between the patient and their clinician,” Gordon told Verywell. “It’s very important to understand that these drugs have not been shown to have any benefit at the moderate or severe stage of the disease,” Gordon said.
People who take blood thinners may not be eligible for Leqembi since that can increase the risk of brain bleeding while on the drug.
Despite Aduhelm’s shortcomings, the Alzheimer’s Association credits the drug with generating interest and advancement in Alzheimer’s drug research. More drugs are in the pipeline for the condition; aLilly medication called donanemabis under FDA review now.
What This Means For YouAduhelm paved the way for innovation in Alzheimer’s treatment. Patients taking Aduhelm—and their caregivers—should meet with their doctor to discuss whether there are alternatives or clinical trials that might be helpful for slowing symptoms of Alzheimer’s disease.
What This Means For You
Aduhelm paved the way for innovation in Alzheimer’s treatment. Patients taking Aduhelm—and their caregivers—should meet with their doctor to discuss whether there are alternatives or clinical trials that might be helpful for slowing symptoms of Alzheimer’s disease.
2 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.FDA grants accelerated approval for Alzheimer’s drug.Alzheimer’s News Today.Alzheimer’s Association welcomes Aduhelm price cut, but presses on.
2 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.FDA grants accelerated approval for Alzheimer’s drug.Alzheimer’s News Today.Alzheimer’s Association welcomes Aduhelm price cut, but presses on.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Food and Drug Administration.FDA grants accelerated approval for Alzheimer’s drug.Alzheimer’s News Today.Alzheimer’s Association welcomes Aduhelm price cut, but presses on.
Food and Drug Administration.FDA grants accelerated approval for Alzheimer’s drug.
Alzheimer’s News Today.Alzheimer’s Association welcomes Aduhelm price cut, but presses on.
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