Frankfurt The new Alzheimer’s drug from the US pharmaceutical company Eli Lilly seems to work better than expected in the early stages of the disease. In these patients, the drug donanemab slowed the progression of the brain-damaging disease by 60 percent, according to study data released Monday.
That’s nearly double the rate Lilly reported in May for the study’s entire treatment group. The data underscores that earlier detection and diagnosis can really change the course of Alzheimer’s, said Anne White, Lilly’s board member, responsible for neuroscience.
However, the treatment also carries risks such as brain swelling – a well-known side effect of drugs like donanemab. Brain swelling occurred in more than 40 percent of patients with a genetic predisposition to Alzheimer’s disease.
Lilly previously reported that 24 percent of the entire donanemab treatment group experienced brain swelling. Bleeding in the brain occurred in 31 percent of study participants in the donanemab group, compared with about 14 percent in the group receiving placebo. In addition, three deaths were associated with the treatment.
“These side effects shouldn’t be taken lightly,” but most cases are managed with monitoring with magnetic resonance imaging (MRI) or stopping the drug, said study leader Liana Apostolova, a professor of Alzheimer’s research at Indiana University School of Medicine.
Doctors are expected to “perform very rigorous MRI safety screening while treating these patients.” Lilly expects the FDA to make a decision on donanemab approval by the end of the year.
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The US pharmaceutical company published the first data in May and stated that all study goals had been achieved. In 1,182 people with mild cognitive impairment or mild dementia whose brains had deposits of two key Alzheimer’s proteins, beta-amyloid and tau, donanemab slowed cognitive decline by 29 percent compared to a placebo. In patients with high tau levels, the drug slowed disease progression by about 17 percent, while the benefit in patients with low to moderate tau levels was 35 percent.
Donanemab, like recently approved Biogen drug Leqembi, belongs to a class of drugs aimed at slowing the progression of Alzheimer’s by clearing deposits of the protein beta-amyloid from the brain. According to Lilly, the treatment effect of donanemab continued to increase over the course of the 18-month study, compared to a placebo, even in participants who stopped taking the drug after their amyloid deposits had decreased significantly.
“At the end of the study, the average patient had been off medication for seven months and still continued to benefit from treatment,” White explained. These results support the idea that donanemab can be stopped once the amyloid is cleared from the brain.
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The full study results were presented at the Alzheimer’s Association International Conference in Amsterdam and published in the journal JAMA. “Whether the harms of these drugs are outweighed by their modest clinical benefits will ultimately only be determined by further data,” said an editorial in JAMA.
Worldwide, 55 million people suffer from dementia, most of them probably from Alzheimer’s according to the World Health Organization (WHO). In 2030, it is expected that there will be 78 million people affected by dementia. Alzheimer’s is difficult to diagnose, especially in the early stages of the disease.
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