WHAT YOU NEED TO KNOW:
- Eisai and Biogen announced promising results from a treatment that targets brain plaques or amyloids in Alzheimer’s patients.
- The phase 3 clinical trial included 1,795 patients with early-stage Alzheimer’s disease.
- The results showed that the treatment slowed cognitive decline by 27 percent compared to the placebo group.
Promising results of a phase 3 clinical trial showed that a new drug, called lecanemab, slowed cognitive decline by 27 percent in Alzheimer’s patients.
Japanese company Eisai and its American partner Biogen jointly developed the drug.
Trial participants had early-stage Alzheimer’s disease. The 1,795 participants were divided into two groups. For 18 months, one group received the drug intravenously on a biweekly basis, and the other group received a placebo.
Results showed “highly statistically significant” slowing of deterioration in the treatment group compared to the placebo group.
Some side effects for about 21 percent of the participants included brain swelling or bleeding.
The same company had rolled out a similar drug, Aduhelm, that targets brain plaque buildup. Data for Aduhelm was not as convincing, however, but it still received regulatory approval from the FDA.
Eisai CEO Haruo Naito said that the lecanemab trials “prove the amyloid hypothesis, in which the abnormal accumulation of [beta amyloid] in the brain is one of the main causes of Alzheimer’s disease.”
Eisai had already applied for accelerated approval from the FDA. Experts are optimistic that the drug will be approved by next year, but it is yet to be known whether it can become widely available.
Physician Riddhi Patira, an assistant professor of neurology at the University of Pittsburgh and an investigator at the school’s Alzheimer’s Disease Research Center, told Changing America in an email, “Ideally, we need to wait for data to be presented or published in a peer-reviewed journal. But the prospect of moving closer to finding treatments for Alzheimer’s Disease, even if that progress is incremental, is promising.”
Biogen CEO Michel Vounatsos stated, “Defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities.”
The FDA still has to thoroughly examine the trial data, which is yet to be released.
Constantine G. Lyketsos at the Alzheimer’s Disease Research Center at Johns Hopkins University cautioned that the potential benefit of the drug to the patient is still very small.
Lyketsos pointed out that since the drug is not a cure and is only meant to slow down the patient’s cognitive decline, continuing the treatment may offer a moral dilemma. He noted that drug companies should clearly state which subset of Alzheimer’s patients could benefit the most from this treatment.
In this case, researchers suggest that the drug would mostly benefit patients who are still in the early stage of the disease.
Source: The Hill