A drug for Alzheimer's disease has been developed by Eisai Co. in conjunction with Biogen Inc., and has won the support of advisers to US regulators. This is paving the way for a forthcoming full regulatory approval that could lead to broader insurance coverage for sufferers of the disease. If approved, it will be the first medication that has clearly been shown to slow the progression of Alzheimer's, which affects over 6 million Americans and an estimated 55 million people worldwide.
Six advisers to the Food and Drug Administration voted unanimously to recommend the traditional approval of the medication, known as Leqembi. This favorable vote was widely expected by analysts after the FDA's staff had submitted a report earlier in the week in support of the drug. During the hearing, the drug was quickly endorsed after a mere twenty-minute discussion, during which every member of the panel agreed that it had been wholly effective in slowing cognitive and functional decline.
Neurologist at Harvard Medical School and panel member Merit Cudkowicz stated, "The evidence for clinical benefit was very clear and very robust...These are meaningful changes for people with Alzheimer's." However, panel members remained concerned about potential risks to certain categories of patients, including those taking specific kinds of anticoagulants. The drug can cause brain swelling and bleeding, which can be exacerbated by anticoagulant use. While some panel members thought patients taking these drugs should be warned against using Leqembi, others thought that there was insufficient data to make a clear decision.
Cudkowicz stated that she was leaning towards recommending that people taking anticoagulants should be excluded from using the therapy, and further stated that additional data and studies were necessary. "This is where I don’t think the benefit outweighs the risk,” she said.
In January, Leqembi was approved by the FDA under the agency's acceleration approval pathway. This was based on its capacity to remove deposits of a toxic protein called amyloid from the brains of Alzheimer's patients. Medicare, which is the US health program for older adults, declined comprehensive coverage for both Leqembi and other similar agents without full FDA approval regarding data showing a positive impact on cognitive decline. This makes the forthcoming FDA decision crucial with regards to Leqembi's expected annual US sales of more than $2 billion according to Bloomberg Intelligence analysts, Marc Engelsgjerd and Sam Fazeli. The FDA is not required to follow the advice of its advisers, but it generally does.
Shares in Biogen were halted on Friday, and Eisai's American depositary receipts closed 7.2% higher in New York. The FDA’s final decision is expected by early July. Recently, the Centers for Medicare and Medicaid Services announced that broader coverage would commence instantly following full approval.