United States: Pharmaceutical company Eli Lilly has announced the successful results of a late-stage clinical trial of its experimental drug donanemab in treating Alzheimer’s disease. The trial involved nearly 1,200 people in the early stages of the disease, and the drug was found to slow the progression of symptoms by 35 percent over 18 months compared to a placebo.
The treatment was measured using a standardised index called the Integrated Alzheimer’s Disease Rating Scale (iADRS), which evaluated the patients’ cognitive ability and capacity to carry out daily activities like managing finances, driving, and conversing about current events.
While experts have praised the results as “remarkable,” some patients experienced serious side effects, including temporary swelling in parts of the brain, which affected nearly a quarter of those treated.
Lilly stated that the incidence of serious brain swelling in the study was 1.6 percent, including two deaths attributed to the condition, while a third might have also died from the treatment.
The company added that it was “extremely pleased” at the study outcome and would submit its results to the US Food and Drug Administration (FDA) as well as other global regulators and hoped to get US approval by as early as the end of the year.
Mr. Mark Mintun, a top Lilly executive in neuroscience R&D, commented that “like many effective treatments for debilitating and fatal diseases, there are associated risks that may be serious and life-threatening”.
According to the World Health Organisation (WHO), more than 55 million people worldwide are living with dementia, presenting a significant challenge to healthcare systems. With the population ageing, the United Nations health agency expects the number of sufferers to rise to 78 million by 2030 and 139 million by 2050.