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The US FDA has granted standard approval to the Alzheimer’s drug Leqembi, developed by EisaiBiogen.

by Swati Gupta

July 7, 2023 21

In a groundbreaking development, the US Food and Drug Administration (FDA) granted standard approval to the Alzheimer’s drug Leqembi, jointly developed by Eisai and Biogen. This historic milestone marks the first time an Alzheimer’s treatment has achieved such recognition, paving the way for broader insurance coverage and access to the medication.

For decades, drugmakers have struggled to find effective treatments for this devastating disease. However, trial data on Leqembi demonstrated its ability to slow the progression of Alzheimer’s by 27% in patients in the earliest stages. This substantial efficacy data played a crucial role in the FDA’s decision.

Despite granting standard approval, the FDA also issued a prominent safety warning in the form of a boxed label for Leqembi. This warning highlights the potential risk of dangerous brain swelling associated with Alzheimer’s drugs in the same class. The inclusion of this cautionary note was considered unexpected by analysts, leading to a decline in Eisai’s stock value during Tokyo trade.

Leqembi is an innovative antibody designed to eliminate the accumulation of amyloid beta protein, a sticky substance found in the brains of Alzheimer’s patients. This targeted approach aims to combat the underlying cause of the disease, offering new hope for patients and their families.

Eisai’s US Chief Executive, Ivan Cheung, expressed his satisfaction with the FDA’s decision, stating, “Today, we believe is a triumph for the Alzheimer’s disease community, after so many years of hard work by so many scientists, physicians, and clinical trial participants and their care partners.”

Initially, Leqembi received accelerated approval from the FDA in January based on its ability to clear amyloid plaques. However, coverage under the US government’s Medicare health plan was limited to patients participating in clinical trials. The standard approval now signifies that Leqembi will be covered by Medicare, as the Centers for Medicare and Medicaid Services (CMS) have extended coverage to a broader patient population. However, reimbursement from CMS will be tied to patient participation in a health agency database known as a registry. This data collection initiative aims to gather further insights into the drug’s effectiveness and real-world outcomes.

Considering that Alzheimer’s primarily affects older individuals, most patients in the United States are insured through Medicare. Consequently, standard approval for Leqembi brings renewed hope for a substantial number of patients who previously faced limited access to this innovative treatment.

CMS Administrator Chiquita Brooks-LaSure acknowledged the significance of the FDA’s decision and its impact on coverage, stating, “With FDA’s decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works.”

The standard FDA approval of Leqembi marks a significant milestone in the battle against Alzheimer’s disease. It represents a major breakthrough for the Alzheimer’s community, offering hope for improved quality of life and a potential shift in the management of this devastating condition. With wider insurance coverage and ongoing data collection efforts, Leqembi’s impact on patients and its role in combating Alzheimer’s will continue to be closely monitored and researched.