New drug for Alzheimer’s should take time to arrive in Brazil – 07/07/2023 – Health

The FDA (agency that oversees drugs and food in the US) granted full authorization this Thursday (6) for the use of the drug lecanemab, marketed as Leqembi, for the treatment of Alzheimer’s.

In clinical studies, conducted in the American country with 1,795 participants aged 50 to 90 years with mild symptoms of , the use of the drug reduced the progression of the disease by 27%.

The drug works by removing the deposit of beta amyloid protein, which, when accumulating in the brain, can lead to initial cognitive loss. As in patients with an initial diagnosis of Alzheimer’s, but still without severe dementia, the protein can already be found, tests such as PET-amyloid (PET scan) can help detect the disease for the initiation of treatment.

The positive results divided opinions, since the occurrence of serious adverse effects, although rare, such as edema (swelling) and cerebral hemorrhages were verified in the study.

Because of this, the FDA restricted the indication to people with mild symptoms of the disease and without an increased risk of cerebrovascular disease. Expanding access for users of the Medicare program, subsidized by the government, is also an issue raised, due to the cost of treatment —about US$ 2,000 per month, the equivalent of almost R$ 10,000.

In Brazil, there is still no approval of the drug. Sought, Anvisa (National Health Surveillance Agency) did not respond until the publication of this text.

Doctors and patients claim that the agency did not receive the request for lecanemab authorization from the laboratory.

Around here, the treatments available both in the public and private network are the same as 20 years ago, explains Claudia Suemoto, associate professor of geriatrics at the USP School of Medicine and coordinator of the university’s Brain Bank.

“These are promising drugs, the first two approved after more than 20 years, but they only serve for some stages of the disease and, for the time being, there is no forecast for use in Brazil, where we continue with the same drugs traditionally used, anti-inflammatory drugs. -cholinesterase agents and memantine”, he explains.

Anticholinesterase drugs (donepezil, galantamine and rivastigmine) act by regulating acetylcholinergic neurotransmitters in the brain, improving cognition, but not delaying the disease. “They serve to reduce the symptoms, like a dipirona that reduces the fever in an infection, but only an antibiotic will fight the bacteria and end the course of the disease”, he explains. They are indicated for all stages, mild, moderate and severe Alzheimer’s.

Memantine acts on the glutamate chain, another type of neurotransmitter associated with cognitive decline. “They are symptomatic drugs, known for a long time, but which also have a shorter period of action.”

For Suemoto, another aspect to be investigated is also how much the removal of beta amyloid can reduce the progression of the disease or how much another protein, TAU, which is deposited later in the clinical picture, plays a greater role in cognitive decline. “We are still learning a lot about the progression of the disease and how this biochemical cascade works to be able to even act with targeted therapies”, says the researcher.

ANOTHER DRUG

In 2021, another drug with an active principle similar to lecanemab, aducanumab, received FDA authorization for the early treatment of Alzheimer’s. The Biogen laboratory, even though it produces lecanemab, is also responsible for producing this drug and submitted the dossier for approval by Anvisa in 2022, but there has still been no approval by the national agency. The commercialization of aducanumab in the US reaches US$ 26,000 per year (almost R$ 130,000).

Innovative therapies, however, are still viewed with caution by specialists, both because of their still-initial character and the high cost.

“The big debate is that in exams [de imagem] they reduce the deposit of amyloid beta, but have not yet been proven to improve the patient’s quality of life and performance”, explains Ivan Okamoto, a neurologist at Nemo (Center for Excellence in Memory) at Hospital Israelita Albert Einstein.

For him, long-term studies can help determine this correlation, but, for now, the high cost is a factor that will even limit access via health plans. “It’s not the last hope, we shouldn’t treat it as if it were the definitive solution for the disease because that could even worsen the emotional state of those patients who don’t have access.”

EARLY DIAGNOSIS

Another point to be debated is whether or not early detection can be indicated, since amyloid-PET exams or CSF analysis (to verify the accumulation of amyloid beta) are very specific and expensive.

“From a research point of view, it is important to know when a patient has Alzheimer’s that is still asymptomatic or very mild, but from an individual point of view there is no such indication yet, because even with this approval in the USA the drugs that reverse the course are still far away. to be accessible to everyone”, ponders Suemoto.

In a study with samples from the USP brain bank, Suemoto and his colleagues saw that around a quarter of the patients with brain lesions caused by beta amyloid deposits did not die due to Alzheimer’s disease, but due to other causes.

ATTENTION TO THE FAMILY AND PREVENTION

Experts also say that care for the family of patients with Alzheimer’s is important, in what they call non-pharmacological treatment. “The diagnosis of Alzheimer’s can, many times, fall like a bombshell in a family. So these promises of miracle drugs call attention, but the reality is that we need services that work to raise awareness and prepare both the family and caregivers to face this disease, which progresses slowly”, he explains.

Prevention is also an important factor, since the risk factors that can lead to Alzheimer’s are known, such as poor diet, sedentary lifestyle, overweight and smoking. “Knowing adequate prevention is more important than thinking about a drug that can generate a false expectation of cure, because we are not there yet.”