Nerve cells affected by Alzheimer’s disease
The news that an experimental Alzheimer’s therapy has reduced patients’ cognitive and functional decline by 27% in a clinical trial is receiving measured responses from prescribers as they await further data, according to a new report.
The drug lecanemab, made by companies Eisai and Biogen, aims to reduce amyloid beta brain plaques linked to Alzheimer’s, thereby slowing its progression. In a phase 3 clinical trial, positive results were seen in patients with early disease, the “most encouraging” results to date of a treatment that targets an underlying cause, according to the Alzheimer’s Association. The drugmakers plan to pursue federal approval in the coming months.
Physicians weigh in
But with trial data not yet reviewed and published, physicians are waiting for more details before calling the news a game changer, according to Stat. The key finding, which amounted to a 0.45-point difference between the groups on an 18-point standardized scale, may be too small for patients and their families to notice, Stanford University neurologist Victor Henderson, MD, told the medical news outlet.
But trial investigator and neurogeriatrician Babak Tousi, MD, of the Cleveland Clinic, said that reducing cognitive and functional decline by a half-point during the 18 months duration of the trial might mean more days of independence for patients, and relief for families and caregivers. Patients at this stage typically decline one to two points within that time period, he noted.
The 0.45 difference may also have a bigger impact on those with less advanced disease, another geriatrician told Stat.
“I’m cautiously optimistic that it could be potentially meaningful for those folks who are in the mild stage,” Mia Yang, MD, of Wake Forest, said.
Potential hurdles
The drug faces some of the same hurdles as did the plaque-targeting drug Aduhelm, also developed by Biogen and Eisai. That treatment was approved — with caveats — by the Food and Drug Administration in June 2021. But its clinical trial results were less clear than those reported for lecanemab, and it ultimately did not win insurance coverage outside of clinical trials from the Centers for Medicare & Medicaid Services.
Eisai and Biogen will not only need to prove that the benefits of lecanemab outweigh any potential side effects, such as brain swelling and bleeding, but must work closely with a generally skeptical CMS to ensure reimbursement that will seem reasonable to patients, prescribers and other federal agencies, according to FiercePharma.
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