29 February 2024

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Alzheimer's drugs

Authorities pushed to fast-track approval of Alzheimer’s drugs after new trial data update

A pair of new Alzheimer’s drugs hitting the market this year could be a game changer in the treatment of Alzheimer’s disease, and experts are pressing regulators to expedite approval so that people in the early stages of the condition can benefit from them. 

Researchers working on Eli Lilly’s donanemab released findings from historic research of around 1,800 participants this week, which confirmed prior reporting in May that early-stage Alzheimer’s disease progression can be reduced by up to 35%. Lecanemab, an Alzheimer’s drugs developed by Eisai and Biogen, was demonstrated last year to reduce the course of the illness by roughly 27% and was licensed for use in the United States this month.

These delays are significant because they may allow those suffering from Alzheimer’s disease to live more independently for longer periods of time, with many medical professionals hoping that new medications will herald a turning point in transforming the debilitating sickness into a manageable condition similar to diabetes.

Dr. Susan Kohlhaas, executive director of research and partnerships at Alzheimer’s Research UK, is among those urging regulators to act quickly to ensure that the new drugs benefit as many people as possible, given the critical role that prompt intervention plays in how well patients respond to the treatment.

Alzheimer's drugs

“We now have two potentially life-changing Alzheimer’s drugs on the horizon, and we need to see rapid regulatory decisions so that people who could benefit from these treatments aren’t left in limbo,” Kohlhaas wrote in The Guardian. “After 20 years of no new Alzheimer’s drugs, people suffering from this disease deserve to know about new treatments as soon as possible.”

Though lecanemab has already been licensed in the United States, regulators in the United Kingdom and Australia have yet to approve either of the drugs, which act by lowering levels of a protein in the brain called cerebral amyloid, which is widely seen as a significant cause for Alzheimer’s disease.

The Donanemab study employed a different Alzheimer’s drugs marker known as tau to quantify disease development in participants and categorise them based on the severity of the disease progression. Disease development was reduced by 35% in individuals with low and medium tau levels, but when high tau participants were included, this percentage plummeted to 22%, emphasising the need of taking these medications as soon as feasible.

“One of the questions we had was: Does the effect grow over time?” In an interview with CNN, Lilly’s chief of research, Dr. Daniel Skovronsky, stated. “That’s important because Alzheimer’s disease is a chronic disease that can last a decade or more.”

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Alzheimer’s drugs Results in early stages

According to Skovronsky, the Alzheimer’s drugs cognitive benefits were visible at every trial stage when compared to the placebo group, and the gap between the two groups expanded over time.

Lilly additionally planned the trial so that if a subject eliminated enough cerebral amyloid, they may be transferred to a placebo and observed indefinitely. By the one-year mark, over half of the participants had switched to a placebo, according to Skovronsky, and those participants continued to benefit even after they stopped taking the drug.

“We were delighted to see that,” Skovronsky remarked. “Once the [cerebral amyloid] plaques are removed, you’ve fundamentally changed the course of the disease in a positive way.”