The Food and Drug Administration (FDA) on Friday granted accelerated approval for Leqembi, a new drug for the treatment of Alzheimer’s. Leqembi is produced by Eisai, a pharmaceutical company based in Japan. Eisai is working with American biotechnology company Biogen to market the new drug.
The FDA’s accelerated approval came after a small study that showed a “significant dose- and time-dependent reduction” of a major indicator of Alzheimer’s known as amyloid beta plaque. Alzheimer’s patients typically show plaque development from beta-amyloid protein grouping between neurons. The plaque buildup affects the proper function of cells.
The expected annual cost of treatment with the new drug has been set at $26,500. The new drug has not yet been approved for coverage by Medicare.
Medical experts have said Leqembi provides modest improvement in patients with minor cognitive impairment or early onset Alzheimer’s disease.
The FDA has warned that there are some potential dangers associated with Leqembi. The agency is incorporating a warning for the drug related to amyloid-related imaging abnormalities (ARIA). Those abnormalities can lead in some cases to serious and life-threatening conditions.
The warning states: “ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure.”
Other side effects that were noted were headache and “infusion-related reactions.”
Full approval of the drug is expected only after the FDA is provided results from a larger study produced by Eisai and Biogen. That data is expected in a few days.
Reports indicate that the more comprehensive study of Leqembi lasted 18 months. It reveals that 17.3% of drug patients experienced some signs of brain bleeding. That compares with 9% of the placebo group with similar symptoms.
The test group also experienced brain swelling at a 12.6% rate, compared to 1.7% of the placebo group.
Around 7% of the test group ended the drug trial due to adverse side effects, and 14% of the trial group experienced some level of “serious adverse events.”
Physicians involved in the study have reportedly said that adverse effects from the drug can be managed with careful monitoring of patient reactions. Scans that indicate swelling or bleeding typically require at least temporarily stopping treatment with the drug.
Vanderbilt University neurology researcher Dr. Matthew Schrag cautioned, “Most patients won’t notice the difference. This is really quite a small effect and probably below the threshold of what we’d call clinically significant.”
He added: “Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience? I have pretty serious doubts.”