In clinical trials, Leqembi, formerly known as lecanemab, slowed the progressive cognitive decline associated with Alzheimer’s. It also reduced proteins that accumulate in the brain associated with the disease.
“Alzheimer’s disease immeasurably disables the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, director of the Office of Neuroscience at the Center for Drug Evaluation and Research at the FDA, in a statement. “This treatment option is the latest therapy to target and affect the underlying Alzheimer’s disease process, rather than just treating the symptoms of the disease.”
Eisai and Biogen are also the makers of Aduhelm, the first Alzheimer’s drug targeting brain proteins to receive accelerated FDA approval. The drug’s approval was controversial: The FDA’s panel of outside experts recommended against its approval based on conflicting data. The Centers for Medicare and Medicaid Services also ruled that patients must be on probation to be reimbursed for the cost of the drug. Sales of the drug were so disappointing Biogen scaled back its program for Aduhelm and fired its CEO.
The FDA did not convene an advisory committee meeting before approving Leqembi. An agency spokesman said the drug is not the first in its class, nor did its application raise any new or unexpected safety concerns.
Although both drugs are antibodies that bind to a protein called amyloid, which is thought to be a major cause of Alzheimer’s disease, Leqembi binds to amyloid proteins in a slightly different way than what does Aduhelm do. It is given by intravenous infusion every two weeks.
The Alzheimer’s Association has asked CMS to reconsider its coverage determination for this particular class of drugs. While the agency is considering that request, it’s unclear when it will make a decision.
“We will continue to rapidly review data on these products as they become available, and we are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes,” CMS Administrator Chiquita Brooks-LaSure said in a statement
Eisai and Biogen asked the FDA to grant Leqembi accelerated approval based on two clinical trials. Under the accelerated approval pathway, companies would have to conduct a third clinical trial to show that the drug benefits patients.
In the time between Eisai’s accelerated approval submission to the FDA and the agency’s decision Friday, the company released the results of a third clinical trial. That data, published late last year, showed the drug modestly slowed the progression of patients’ symptoms while reducing levels of amyloid in the brain.
Eisai has stated that he does not believe two of those deaths are related to Leqembi. Still researching the third one.
Wednesday, doctors at Northwestern University published a letter in the New England Journal of Medicine detailing the case of a patient who died after receiving treatment for a stroke after receiving Leqembi. The authors could not conclude that the patient’s death was a result of the drug, but noted that it would be “unusual” for the patient to die from the stroke treatment alone.
On the drug’s label, the FDA stated that Leqembi should only be taken by patients in the early stages of Alzheimer’s disease with confirmed amyloid in the brain. Patients should also be screened for signs of swelling before starting treatment and subsequently after the fifth, seventh and 14th infusion of the drug.
Eisai has said it plans to ask the FDA to consider Leqembi for a traditional approval pathway using new data from its Phase III trial. In a statement, the FDA said it expects to receive that data soon.