A new Alzheimer’s drug has shown promise in its final testing stage and is now moving toward federal approval.
The drug, lecanemab, was created by drug makers Biogen and Eisai Co. and has shown cognitive success in its third phase of testing.
After 18 months of testing lecanemab versus a placebo on 1,795 patients with early Alzheimer’s, Eisai said it will present the findings at the Clinical Trials on Alzheimer’s Disease Congress in late November. The company also plans to submit its data to the Food and Drug Administration for approval by March 2023.
The study, which administered 10mg of lecanemab bi-weekly, showed that the drug reduced cognitive decline by 27%. Although brain scans did show swelling and minor bleeding in some patients, research showed they rarely caused symptoms.
Cognitive ability was tested based on interview questions with the patients regarding memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
Lecanemab aims to bind to the protein amyloid beta – a harmful protein mostly found in the brains of Alzheimer’s patients – helping to remove the protein in the early stages of the disease to lower its impact.
According to the lecanemab news release, criteria for the study allowed patients living with a broad range of medical issues, including things like hypertension, diabetes, heart disease, obesity and renal disease, which makes the tested demographic comparable to those on Medicare.
CNN Chief Medical Correspondent Dr. Sanjay Gupta said on a Sept. 28 newscast that if the drug is approved it could help people with Alzheimer’s function more independently.
“It’s early in terms of actually collecting this data,” Gupta said, “but it could be a very big deal if it all holds.”
The study has not yet been officially reviewed, but the FDA put lecanemab on priority approval.