Called Leqembi, the drug is indicated for patients in the early stages of the disease; but there are relevant questions about its safety and real benefit in everyday life
NEW YORK TIMES – The Food and Drug Administration (FDA) gave full approval to the drug on Thursday Leqembi for patients in the early stages of Alzheimers. In parallel, Medicare, a health care program for those over 65, said it would cover 80 percent of drug costs, or about $26,500 a year.
The decisions by the two federal agencies are expected to significantly increase access to the drug in the United States, but also pose a dilemma for patients and their families. After all, there are many factors to consider. Below are answers to some crucial questions.
How well does the drug work?
Leqembi it’s not a cure for Alzheimer’s disease and does not improve patients’ memory or cognition. It also doesn’t stop the disease from getting worse. What Leqembi can do is moderately slow cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial suggest that, among these people, the drug can delay decline by about five months over an 18-month period.
How the drug affects a patient’s daily life is likely to vary greatly. For some people, Leqembi can mean several extra months to be able to follow a recipe, organize finances, or perform other tasks unaided. For others, the impact can be much more subtle, even barely noticeable.
Are there any risks in using the new medicine?
YES. Drug may cause swelling or bleeding in the brainwhich is usually mild or moderate and resolves on its own. But it can also be serious and, in rare situations, fatal. The FDA was so concerned about these side effects that it requests a “black box warning” — the most urgent level — on the drug’s label, saying it can cause “serious and life-threatening events.”
Patients most at risk include those taking blood thinners, those who have had more than four microscopic bleeds in the brain and those with a mutation in the APOE4 gene, especially if they have two copies of the mutation. These people, along with their doctors, must weigh the risks and a desire for a drug that could modestly slow cognitive decline.
A large clinical study of the drug found that almost 13% of patients treated with Leqembi developed brain swelling, but most of these cases were mild or moderate. Less than 2% of patients who received the placebo experienced such swelling. Most brain swelling does not cause any symptoms and usually resolves within a few months.
About 17% of patients treated with Leqembi experienced bleeding in the brain, compared with 9% of patients treated with placebo. The most common symptom of brain hemorrhage was dizziness, according to the study.
Who can take Leqembi?
Leqembi – which is to be given as an intravenous infusion in a doctor’s office or clinic every two weeks – will be available in the US for people diagnosed with Early stage Alzheimer’s and for those with a pre-Alzheimer’s condition called mild cognitive impairment.
About 1.5 million Americans fit this description. Another 5 million with Alzheimer’s won’t qualify for Leqembi because the disease has progressed too far.
The drug’s label, required by the FDA, instructs doctors not to treat patients without tests to confirm they have one of the hallmarks of Alzheimer’s disease: a buildup in the brain of the protein amyloid-beta that Leqembi targets. Amyloid levels can be assessed with PET scans, lumbar punctures or blood tests as they become available in the country.
Source: Terra
Ben Stock is a lifestyle journalist and author at Gossipify. He writes about topics such as health, wellness, travel, food and home decor. He provides practical advice and inspiration to improve well-being, keeps readers up to date with latest lifestyle news and trends, known for his engaging writing style, in-depth analysis and unique perspectives.
