Alzheimer’s Drug Leqembi Receives Accelerated Approval from FDA

Earlier this year, the Food and Drug Administration (FDA) granted Leqembi, which is only the second drug of its kind, with an accelerated approval. Leqembi is part of a newly emergent class of drugs that target the pathophysiology of Alzheimer’s, instead of merely treating the disease’s progressive symptoms. Per the FDA’s statement, researchers are designing this new class of Alzheimer medication to “target and affect the underlying disease process of Alzheimer’s”, marking important scientific step forward in treating the debilitating disease.

What is Alzheimer’s and Who Does it Affect?

More than 6.5 million Americans suffer from Alzheimer’s. The disease is nothing short of a cruel one; it is an irreversible brain disorder that destroys a person’s memory and thinking skills, and eventually, takes away their ability to carry out simple tasks like feeding themselves, getting dressed and using the bathroom. The disease not only wreaks havoc on the lives of the people experiencing it directly, but it can also alter the quality of life of their loved ones and caregivers. Though much research has been done on the subject, there is still plenty left for us to learn about Alzheimer’s. What we do know, however, is that the disease is typically characterized by significant brain changes like amyloid beta plaques and neurofibrillary, or tau, tangles. These changes result in the loss of neurons and the connections that they make, which compromises a person’s ability to think clearly and recall memories.

Age is the number one risk factor for Alzheimer’s, with most people beginning to experience symptoms after the age of 60 to 65-years-old. Senior citizens who are African American and Hispanic/Latino are more likely to suffer from Alzheimer’s than white adults in the same group. Other risk factors for the disease include gender (women face a higher risk for developing Alzheimer’s than men do), having experienced a moderate or severe head injury, having heart disease, stroke, high blood pressure, diabetes or obesity, having an immediate family member with Alzheimer’s and engaging in limited physical, mental and/or social activities.

One of the most typical, early symptoms of a person who may be developing Alzheimer’s is worsening or more frequent memory loss and/or general confusion about time or place. For example, the person suffering from the disease may start to demonstrate confusion about where they live or how to get to a place they visit regularly. According to the National Institute on Aging (NIA), some other early symptoms that may present in individuals who are developing Alzheimer’s include:

• Changes in thinking
• Shifts in language skills like having problems handling money or struggling to read, speak or write
• Changes in a person’s mood, which lead to them becoming withdrawn from work and/or social activities
• Poor judgment that leads to bad decision making
• Losing track of dates or knowing their own personal location
• Difficulty completing tasks like bathing
• Repeating questions or forgetting recently learned information
• Wandering and getting lost
• Increased anxiety and/or aggression
• Taking longer than normal to complete normal daily tasks
• Loss of spontaneity and sense of taking initiative
• Challenges in planning and/or problem solving

What Does Leqembi Do and Who is Eligible to Take it?

The FDA approved Leqembi under its Accelerated Approval pathway, which allows the agency to grant certain drugs with approval so long as they treat a serious condition where there is a current, unmet medical need. The agency only grants this type of approval for drugs that show they are “reasonably likely” to provide clients with clinical benefits. The FDA granted Leqembi with partial approval earlier this year, granting it with full approval just last month. Although the drug cannot reverse memory loss and does not cure Alzheimer’s itself, it is the first drug of its kind to demonstrate that it slows the progression of the disease for people who are in its early stages. According to researchers, the drug works by targeting the buildup of amyloid plaques in the brain, removing them. Data indicates that it is Leqembi’s removal of these plaques that slows the disease’s progression.

About 15-20% of people who suffer from Alzheimer’s are eligible to receive Leqembi, since they are in an early stage of the disease and experience mild symptoms. Individuals who are eligible to receive the drug will receive it via intravenous (IV) transfusion every two weeks at an infusion center. So far, some recipients have had a slight reaction to the medication, like feeling mild anxiety or shortness of breath. In most patients, these side effects go away on their own without further issue. However, some patients have experienced more serious complications, such as small areas of the brain becoming slightly swollen from bruising. Some areas of the brain may also experience small amounts of bleeding, or microhemorrhages. These microhemorrhages usually do not cause symptoms and the brain bleeds resolve without medical intervention, but in some cases, individuals have experienced headaches, confusion or even stroke-like symptoms. In rare cases, these complications have been fatal.

More Research on Leqembi’s Potential Benefits Still Being Conducted

Researchers suggest that if Leqembi is given to patients early enough, that it could possibly help prevent the disease from developing any further. Current scientific knowledge suggests that the development of amyloid proteins (which is what turns into amyloid plaques in someone’s brain) is what starts the person on the path of developing Alzheimer’s. Researchers hope that if they treat patients with an anti-amyloid therapy such as Leqembi that it could stop the disease from developing altogether, though significantly more research is necessary to determine if this is possible. Because this may be such a remarkable scientific breakthrough, we will be sure to update our readers as this story continues to develop.

To learn more about the FDA’s Accelerated Approval pathway for certain drugs like Leqembi, visit: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval. You can read more about the agency’s approval of Leqembi by reading its press release here: https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment. If you have any additional questions about you or a loved one’s potential eligibility for taking Leqembi, contact a trusted medical professional.

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