Boston: A successfully injected version of Eisai and Biogen’s Alzheimer’s medication, Leqembi, works just as effectively as the current intravenous administration in removing toxic brain plaques. However, the analysis presented by Eisai on Wednesday showed higher rates of serious side effects.
In the review conducted by the Japanese pharmaceutical company, data from 72 patients with early Alzheimer’s who received Leqembi through subcutaneous injection was compared to prior pivotal trial results from 898 patients who received the drug through infusion.
The intravenous (IV) form of Leqembi gained approval in the United States based on a larger 18-month study that demonstrated a 27% decline in cognitive function for individuals with early Alzheimer’s disease by removing sticky clumps of beta amyloid from the brain.
A weekly shot of Leqembi, administered as two consecutive injections, could simplify the use of this groundbreaking Alzheimer’s treatment. It may allow patients to receive the drug at home instead of traveling to an infusion center twice a month.
The latest data presented at the Boston Clinical Trials on Alzheimer’s Disease meeting indicates that, after six months of treatment, the shot form of Leqembi removed 14% more amyloid than the approved IV formulation.
Subcutaneous Leqembi resulted in blood concentration levels of the drug being 11% higher compared to the IV version.
The rate of side effects related to infusion or injection was lower for the subcutaneous formulation, but the rate of serious side effects was higher.
For the subcutaneous group, the incidence of brain swelling, known as ARIA-E, was 16.7%, while for the IV group it was 12.6%.
ARIA-H, or brain bleeding, occurred in 22.2% of the subcutaneous patients compared to 17.3% of the IV group.
“We believe that the safety aspect remains consistent,” said Priya Singhal, Biogen’s head of development, in an interview.
“Due to it being a very small cohort,” she commented on the 72-patient group, “one or two cases can significantly swing the numbers.”
Eisai and their U.S. partner Biogen announced plans to seek U.S. approval for subcutaneous Leqembi by the end of March, based on data from 394 patients.
Concurrently, Eisai presented an analysis of a small subgroup of patients from their pivotal trial who had early Alzheimer’s and low levels of tau, a second protein associated with disease progression and brain cell death.
The analysis revealed that among the low-tau population, 60% of patients experienced cognitive function improvement compared to 28% in the placebo group.
Michael Irizarry, head of clinical research at Eisai’s neurology division, acknowledged in an interview that Alzheimer’s disease typically does not progress much in individuals in the earliest stages of the disease. However, he stated that the data “supports treating as early as possible.”
The U.S. government and Eisai are currently testing the effects of administering Leqembi early to determine if it can prevent dementia symptoms in individuals who are still cognitively normal but have amyloid in their brain.
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