New Delhi: Four months after the US Food and Drug Administration (USFDA) approved the use of lecanumab, a monoclonal antibody drug, to treat Alzheimer’s disease, another similar treatment for Alzheimer’s, US-based Eli Lilly and Co’s Donaneb, The manufacturer of the medicine has been in news ever since. announced promising results from its Phase 3 clinical trials last week.
Alzheimer’s disease, the most common type of dementia affecting an estimated 55 million people globally according to the World Health Organization, affects a person’s memory and thinking skills. Researchers have been trying to find a cure for it for decades, but have had little success. As per reports.
Monoclonal antibodies are a type of protein that is created in a laboratory and works against certain conditions like cancer and various other diseases by binding to specific targets in the body.
As pharmacological treatments for Alzheimer’s disease have so far been largely disappointing – in terms of actual clinical results – the back-to-back “promising” results for the two drugs were taken by many physicians as a sign that I believe that degenerative disease can be cured.
On May 3, pharma major Lilly said in a press statement that the results of a phase three trial of donenumab, conducted over an 18-month period and based on 1,736 participants aged 60 to 85, had shown that the drug improved cognitive performance. and had slowed functional early symptom decline by 35 percent in people with Alzheimer’s disease.
Participants on donanumab had 40 per cent less decline in their ability to carry out activities of daily living at 18 months of taking the drug, the statement said, which has been described by the media as a “breakthrough development”.
The makers have meanwhile said that they will apply for USFDA approval for donanemab as early as July this year.
On the other hand, in November last year the results of phase 3 lecanumab clinical trials were released by Christian Co and Biogen, which showed that the drug reduces beta amyloid burden on the brain to some extent.
Beta amyloid is a class of protein, the buildup of which can severely affect the functioning of many organs, including the brain. Research has shown that beta amyloids build up in Alzheimer’s patients as well.
Experts, however, are cautious about celebrating drugs. Both manufacturers have also acknowledged that there are some potential side effects of its use.
warnings
According to Dr. Rajeev Jayadevan, a physician and medical researcher based in Kerala, when discussing new treatment modalities for Alzheimer’s, it may be important to understand two basic facts.
Jayadevan told ThePrint, “First of all, while beta amyloid is associated with Alzheimer’s, it does not in that sense cause the disease.
They said that while beta amyloid is thought to be an effect or consequence of Alzheimer’s disease, it is currently understood that it is probably one of the byproducts of the process that induces Alzheimer’s, rather than an etiological agent.
Therefore, removing beta amyloid should not equate to removing the cause of Alzheimer’s, as in the case of getting rid of bacteria that cause infection, he stressed.
The second caveat, Jayadevan said, is that severe and fatal bleeding in the brain is now known to occur with both of these monoclonal antibody treatments.
“It’s obviously because that’s [monoclonal] The antibodies that remove beta amyloid from blood vessel walls are somehow the result of their structural disruption,” he said.
Side effects
Donenumab, like lecanumab, can cause some side effects, such as swelling and bleeding in the brain that can prove fatal in some cases, as shown in trial results. According to Lilly, three people died because of these adverse events during the donnemab trial.
Similar side effects were also found during the lecanumab trials.
“Thus, the benefit of the drug needs to be weighed against the small but significant risk of developing serious complications,” Jayadevan said. Safety and efficacy aspects related to drugs.
Dr Praveen Gupta, principal director and head of the department of neurology at Fortis Memorial Research Institute in Gurugram, said that what remains to be seen is whether the new Alzheimer’s drugs change the long-term natural history of the disease.
“Apart from the fact that they are very expensive, there are some serious side-effects associated with these drugs,” he added, even though the drugs are still a few years away from being launched in India.
He added: “Therefore their cost-benefit ratio needs to be analyzed in order to improve the long-term life and care of dementia patients.”
(Edited by Poulomi Banerjee)
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