The US Food and Drug Administration (FDA) approved Donanemab on Tuesday (2), a monoclonal antibody designed to slow the progression of early symptomatic Alzheimer’s disease.
Donanemab, manufactured by Eli Lilly, a laboratory based in Indianapolis (USA), works by helping the body remove the accumulation of amyloid plaque in the brain, a hallmark of Alzheimer’s disease.
The drugmaker said the drug would be sold under the name Kisunla and would cost $695 per vial before insurance, which would equate to $12,520 for a six-month course of treatment or about $32,000 for a year, depending on when the patient completed the course.
Laboratory has managed to develop an effective medicine to slow down Alzheimer’s (Image: Atthapon Raksthaput/Shutterstock)
Donanemab is not a cure, but clinical trials have shown that it slows the progression of Alzheimer’s, allowing people to live independent lives for longer and safely participate in everyday activities.
According to g1, Eli Lilly told an FDA advisory committee in June that late-stage clinical trial data showed “highly significant results” for people who took Donanemab.
The risk was about 35 percent lower of disease progression over a year and a half compared with those taking a placebo. FDA advisers voted that the treatment appeared safe and effective.
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Although rare, some serious adverse events occurred during the drug trial, occurring in only 2% of patients; Participants taking Donanemab had a slightly higher death rate: 2%, compared with 1.7% of those taking placebo; Three people died while taking the drug after developing ARIA, microbleeds known as amyloid-related imaging abnormalities.
Drug approval brings important progress in the fight against Alzheimer’s (Image: Green Apple/Shutterstock)
Because most ARIA incidents occurred in the first six weeks of the trial, Lilly told FDA advisers that it added another MRI scan to the trial before administering the second doses in order to detect people with asymptomatic ARIA.
If it were detected, providers would stop treatment so it could resolve and not become more severe or symptomatic.
Kisunla was approved with instructions that prescribers may consider stopping treatment if they see improvement based on brain scans. The ability to complete treatment after a limited period of therapy could reduce the cost of the drug.
The Alzheimer’s Association celebrated the announcement of the treatment’s approval. “This is real progress. Today’s approval gives people more choices and greater opportunities to have more time,” Dr. Joanne Pike, the group’s president and CEO, said in a press release.
