FDA Approves Alzheimer’s Drug Leqembi with Significant Safety Risks
Thursday saw a significant development in the treatment of Alzheimer’s disease as the Food and Drug Administration (FDA) granted full approval to the drug Leqembi. The approval marks the first time in two decades that an Alzheimer’s drug has received full approval, indicating solid evidence of potential benefit. Medicare has also announced that it will cover a large portion of the high cost of the drug, paving the way for widespread use.
Leqembi is not a cure for Alzheimer’s and cannot reverse or stop the progression of the disease. However, data from a large clinical trial suggests that it can modestly slow cognitive decline in the early stages of the disease. Administered every two weeks as an intravenous infusion, the drug may delay decline by about five months over an 18-month period for individuals with mild symptoms.
Despite the potential benefits of Leqembi, experts in the field have expressed uncertainty about its noticeable impact on patients and their families. The drug carries significant safety risks, including cases of brain bleeding, some of which have been fatal. The FDA has issued a black-box warning, the most urgent level of warning, on the drug’s label to highlight these risks.
Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, stated that the risks associated with Leqembi are prominent, with potential brain bleeding or swelling causing disability if not detected in time. In contrast, the benefits of the drug are more subtle and may not be perceived by patients in a short amount of time.
Medicare has agreed to cover 80 percent of Leqembi’s high cost of $26,500. However, patients may still be burdened with thousands of dollars in co-payments. The drug’s availability and affordability remain a concern for many individuals.
Eisai, a Japanese pharmaceutical company, led the development of Leqembi in partnership with the American company Biogen. Biogen is also the maker of the controversial Alzheimer’s drug Aduhelm, which received approval despite inconclusive evidence of potential benefit. Leqembi’s approval is based on clearer evidence supporting its effectiveness, according to Alzheimer’s experts.
Approximately 1.5 million people in the United States are estimated to be in the early stages of Alzheimer’s, while five million have already progressed too far to be eligible for Leqembi. The drug is primarily intended for those with mild dementia or mild cognitive impairment.
Certain patient groups, such as those taking blood thinners or with specific gene mutations, may be at higher risk of brain swelling and bleeding when using Leqembi. The FDA’s black-box warning recommends genetic testing to assess a patient’s safety risk before prescribing the drug.
The approval of Leqembi by the FDA means that Medicare will cover the drug for eligible patients. However, the cost remains a concern, with estimates suggesting that treatment could exceed $90,000 per year when factoring in medical visits and required brain scans.
Despite the registry requirement imposed by Medicare, which some advocacy groups criticize as an unnecessary barrier to access, medical experts believe that these programs are common and easy to comply with. The registry will provide valuable data to assess Leqembi’s benefits and harms.
Further trials are warranted to determine the long-term efficacy and safety of Leqembi, and the scientific community remains divided on its overall value. Balancing the modest benefits with the significant safety risks of the drug is a complex decision for patients and their families.
As Leqembi becomes more widely available, it remains to be seen how patients and healthcare providers will navigate the potential benefits and risks associated with this groundbreaking Alzheimer’s treatment.