Debate over Alzheimer’s drug approved by FDA a month ago reopens

Rapid drug approval on June 16 aportanumab for Alzheimer’s patients by the United States Drug Regulatory Agency, known as the FDA (for its acronym in English), sparked a heated scientific debate in the United States, with researchers divided over its effectiveness and whether the approval route would provide useful therapies for people with conditions such as amyotrophic lateral sclerosis (ALS), Huntington’s disease and Parkinson’s disease.

One month after approval this new Drug to treat Alzheimer’s disease, US regulators published this Thursday new prescribing instructions that will likely limit its use. The FDA said the goal of the change is to respond to confusion between doctors and patients about who should use the remedy, whose approval last month sparked a intense backlash.

The drug, whose brand name is Aduhelm, had been claimed by patient and family organizations pushing for research and approval of more effective treatments, but dementia experts have raised objections. These experts disagree on how the clinical trials were conducted and point out that there is still uncertainty about its true effectiveness in fighting the disease.

The drug was developed by the Biogen laboratory in collaboration with Eisai. The company had completed two Phase 3 trials earlier, saying they failed. However, after reviewing his data, heThe company found that in one of these studies, patients who received a high dose of aducanumab for a long time benefited from it. Having this data, he submitted the application to the FDA to approve the drug.

The manufacturer Biogen announced the change on Thursday, indicating that the goal of the update is to “Clarify” who were the patients studied during tests carried out by the laboratory and resulting in an approval. The FDA invited the company to clarify the label and approved the text.

“After learning about these concerns, the FDA determined that the prescribing information could be clarified in order to clear up this confusion.The agency said in an emailed statement. Despite the update, the FDA added that “some patients may benefit from continued treatment“If his Alzheimer’s disease progresses.

Alzheimer’s disease is a progressive neurological disease that affects the thinking and independence of millions of people around the world. Currently, more than 40 million people around the world are living with Alzheimer’s disease. But it is also the third leading cause of death in people over 65, after cancer and cardiovascular disease.

Alzheimer’s disease is usually diagnosed more in people over 65, but it starts earlier with subtle neurological changes that occur over the years, or even decades, before symptoms appear. Many people have the first, often unidentified, signs of mild cognitive impairment.

In 1987, the first clinical trial on the disease was launched. Since 1998, 100 drugs have been studied, including a vaccine in mice. But only 5 drugs have been authorized They can help control some of the symptoms. There are many treatments and diagnostic tests that are under study and in various stages of clinical trials.

Last November, an FDA advisory committee voted by majority against the recommendation for aducanumab approval. They argued that the data did not convincingly show that the drug slows cognitive decline. Later, three members of the advisory committee wrote a point-by-point review of the tests. Other scientists and An independent panel of experts says aducanumab has not demonstrated a compelling benefit that outweighs its safety risks.

James E. Galvin, the University of Miami (UM) neurologist who was in charge of clinical studies of the new drug to stop the progression of Alzheimer’s disease, avoided getting into controversy over its approval in the states -United and affirmed that patients with amyloid plaques should be ‘excited’.

The researcher explained that aducanumab had a 71% reduction in plaques considered to be the cause of the disease and was also optimistic about the new “approaches” authorities to evaluate drugs for this degenerative disease.

Despite the resistance created by the “urgent” approval of this treatment due to doubts about its effectiveness, Galvin said that patients living with Alzheimer’s disease, their families and “much of the doctors and researchers” should be “excited”.

The founder and director of the Comprehensive Center for Brain Health at the UM Miller School of Medicine Health System, however, acknowledged that “there will also be doctors and researchers who will oppose the final approval.”

Galvin said the difficulty in finding cures for the ailment lies in that it is a chronic degenerative disease that affects the brain, “which is very difficult to study”. “Memory is a symptom that is difficult to measure and improve”, qualified.

“I believe that FDA’s approach could change the way Alzheimer’s drugs are evaluated and lead to an explosion of new research as has happened with cancer treatments over the past 10 years, ”he predicted at the time.

Alzheimer’s disease is the leading cause of dementia and covers between 60 and 70% of cases worldwide, according to WHO data. Dementia includes problems with memory, language, attention, or reasoning which, due to their severity, prevent a person from carrying out daily activities independently. In this context, dementia is not necessarily accompanied by behavioral or mood symptoms, although these may be present.

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