Experts urge health regulators to approve ‘turning point’ dementia drugs
Posted on the 17th July 2023
Health regulators are being urged to rapidly approve two game-changing dementia drugs to ensure millions globally benefit from them.
The calls come as the final results from a landmark study confirmed that donanemab, made by Eli Lilly, slowed cognitive decline in Alzheimer’s patients by 35 per cent.
Meanwhile, trial results published last year showed that lecanemab, made by Eisai and Biogen, reduced the rate by 27 per cent.
Health leaders have hailed the arrival of the drugs as a “turning point in the fight against Alzheimer’s” and hope the disease could become as manageable as conditions such as diabetes or asthma.
Dr Susan Kohlhaas, Executive Director of Research and Partnerships at Alzheimer’s Research UK, has said it is critical for regulators to act promptly to avoid patients experiencing frustrating waits for clinically effective treatments.
“We now have two potentially life-changing Alzheimer’s treatments on the horizon and we need to see rapid regulatory decisions so people who could benefit from these treatments aren’t left in limbo,” Kohlhaas said.
“After 20 years without new Alzheimer’s medicines, people affected by this disease deserve to have answers about new treatments as quickly as possible.”
It is understood that Eli Lilly has applied for approval for donanemab in the US, and will do so in the UK in the coming weeks.
Lecanemab received the green light in the US earlier this month but is still waiting for approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Final trial results of donanemab, published in the Journal of the American Medical Association and presented to the Alzheimer’s Association International Conference in Amsterdam, concluded that, after 76 weeks of treatment, it could slow clinical decline by 35.1 per cent in people with early Alzheimer’s whose brain scans showed low or medium levels of a protein called tau.
When the results were combined for people who had different levels of this protein, there was a 22.3 per cent slowing in disease progression.
That means people with the disease could still go about performing day-to-day tasks, including shopping, housekeeping, managing finances and taking medication.
The final results of the trial – known as TRAILBLAZER ALZ-2 – examined the safety and efficacy of the drug. Researchers studied almost 1,800 people with early-stage Alzheimer’s.
Half of them received a monthly infusion of donanemab – which works by removing a protein called amyloid that builds up in the brains of people with Alzheimer’s – and the other half were given a placebo over 18 months.
Researchers found that, among a small number of people in the study, there were some serious side-effects, such as brain swelling.
Meanwhile, three deaths in the donanemab group and one in the placebo group were considered “treatment-related.”
Alzheimer’s is the most common cause of dementia, one of the world’s biggest health threats.
The number of people living with dementia globally is forecast to nearly triple to 153 million by 2050, and experts have said it presents a rapidly growing threat to health and social care systems in every community, country, and continent.