An experimental Alzheimer’s drug made by Eisai Co. and Biogen Inc. slowed the rate of cognitive decline among patients in the early stages of the illness in a large study, improving its chances of future approval.
The drug, lecanemab, reduced cognitive and functional decline by 27% in the test group, compared to those on a placebo treatment, over 18 months in a Phase 3 study of nearly 1,800 participants in the early stages of Alzheimer’s, the pharmaceutical companies said.
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“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Biogen CEO Michel Vounatsos.
The results may prove promising for the drug’s approval, as Alzheimer’s is a progressive disease with no known cure that affects memory, thinking, and behavior. While there are treatments available, they only manage symptoms of the disease, which over 6 million people in the United States are living with. Eisai, which would co-promote the drug with Biogen, has already sought accelerated approval from the U.S. Food and Drug Administration.
“These are the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date,” the Alzheimer’s Association said in a statement. “For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanamab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions.”
The study assessed patients’ cognitive and functional performance in six areas, including memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care. Full results of the study will be presented at a conference in November and published in a peer-reviewed medical journal.
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Last year, Biogen’s Aduhelm became the first new therapy for the disease in nearly two decades to receive approval after other drug candidates failed to show positive results. It has faced challenges on the market, with an initial price tag of $56,000 annually, which Biogen later cut, and Medicare limiting coverage of the drug amid concerns over its effectiveness.
