ATLANTA — Independent advisors to the U.S. Food and Drug Administration (FDA) unanimously voted Friday to recommend the Alzheimer's drug Leqembi receive full approval.
Leqembi, made by Eisai and Biogen, was granted accelerated approval by the FDA in early January. According to the FDA, accelerated approval is allowed when drugs of severe conditions meet an unmet medical need and a drug is shown to have an effect that is likely to predict a benefit to patients.
Dr. Jonathan Liss, a neurologist with a subspecialty in memory disorders like Alzheimer's is the founder and primary doctor at the Columbus Memory Center (CMC). He worked on Leqembi during its latest clinical trial at the CMC, which is a dementia and Alzheimer's disease prevention and treatment center in Georgia.
The clinical trial for the drug lasted 10 years and included hundreds of screenings.
"Leqembi will be the very first drug that shows a substantial change in the disease process and a proven slowing of the disease for people who are on the pathway towards Alzheimer's disease and people with early Alzheimer's disease," Dr. Liss explained. "So it's a big breakthrough for early sufferers disease."
The Alzheimer's drug is administered twice a month via IV. If the drug receives full FDA approval, patients would have to come into a doctor's office for treatment.
"The latest trial, in particular, showed that every measure that was entertained for the study was successful," Dr. Liss said.
The drug costs $26,000 annually, making it inaccessible to most people in the U.S. A factor that some families lament, hoping the drug can be subsidized in some way to give patients a fighting chance in delaying the disease.
The unanimous vote by FDA advisors Friday clears a path for the FDA to make the drug more accessible -- a decision that will come in the following months.
The agency's decision will determine whether Medicare broadly covers the treatment. Medicare has said it would broadly cover the drug if the FDA fully approves Leqembi.
The drug is available currently in the U.S., it was originally made available after the FDA voted to accelerate its approval in January. Few people have access due to its cost and Medicare only covers people participating in clinical trials.
How much of a difference would Leqembi make if fully approved
Clinical trials for Leqembi have shown that Alzheimer's can be slowed down by about 27% for those showing early signs of the disease and those in its first stages, according to Liss.
"This roughly means that probably a person who takes the medication will have somewhere between an extra two and three years in that particular stage of disease," Liss said.
The drug would give people more time before their Alzheimer's disease and health worsened. Liss pointed out that the drug would make a difference to those the disease impacts the most.
"Let's remember that about half of all sufferers of the disease are age 85 and above," Liss said. "So if we add another five years of truly high-quality time in life, that's a remarkable statement for those 85-year-olds."
Most people with the disease are 65 and older, the Alzheimer Association reports. After age 65, the risk of Alzheimer's doubles every five years.
Brain swelling and bleeding were found to be serious health risks of Leqembi that can be life-threatening, according to the FDA. It's expected to decide whether to grant the drug full approval by early July.
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