FDA Advisors Evaluate Whether Alzheimer's Drug Leqembi Should Get Full Approval

(RTTNews) - A panel of independent advisors convened by the Food and Drug Administration is currently meeting to determine whether Leqembi, an Alzheimer's drug developed by Eisai and Biogen, should receive full approval.

Although the FDA is not obligated to follow the advisors' recommendation, a favorable vote would potentially pave the way for the treatment's approval later this summer.

The FDA is expected to make a final decision on Leqembi on July 6, which will directly influence whether Medicare provides comprehensive coverage for the medication. Currently, Medicare has significantly restricted coverage due to the drug's previous expedited approval process.

Leqembi marks the second Alzheimer's treatment from Eisai and Biogen to undergo FDA review, following the controversial approval of the drug Aduhelm in the summer of 2021. Despite 10 out of 11 advisory committee members concluding that Aduhelm did not demonstrate clinical benefit, the regulatory body granted it expedited approval. Subsequently, a congressional investigation revealed irregularities surrounding the approval process of Aduhelm.

Ahead of Friday's meeting, FDA staff indicated in a briefing document that the clinical trial data submitted by Eisai appeared to confirm the clinical benefit of Leqembi for Alzheimer's patients. This suggests that the agency may lean toward approving the treatment this summer. In clinical trials, Leqembi demonstrated a 27 percent slowdown in cognitive decline among early Alzheimer's patients. However, the drug also carries serious risks of brain swelling and bleeding, requiring twice-monthly intravenous infusions.

Notably, the advisory committee for Leqembi consists of only six voting members, an unusually small size. Dr. Teresa Buracchio, acting head of the FDA's neuroscience office, explained that conflicts of interest led several experts to recuse themselves from the meeting. Despite the reduced panel size, Buracchio assured that the group possesses the necessary expertise to engage in a comprehensive discussion on the topic.

Buracchio further mentioned that the inclusion of panel members in Friday's meeting was influenced by a letter from the Alzheimer's Association, advocating for Leqembi's full approval. One FDA advisory committee member, Dr. David Weisman, had initially been granted permission to participate in the meeting but subsequently recused himself after signing the letter. Acting Chair Dr. Robert Alexander, despite holding stocks in competing companies, was granted a waiver to lead the panel due to his invaluable expertise.

Currently, Leqembi is available on the U.S. market through fast-track approval obtained in January. However, limited coverage by Medicare restricts access to the treatment to individuals participating in clinical trials. Since no trials are currently underway, most seniors can only obtain Leqembi if they can afford to pay out of pocket. The drug carries a list price of $26,500 per year. Medicare has committed to expanding coverage upon the FDA's full approval, while the Veterans Health Administration already covers the treatment for veterans.

Friday's advisory committee meeting holds significant importance for members of Congress and organizations advocating for Alzheimer's patients. Senator Bernie Sanders, chair of the Senate Health Committee, has criticized the price of Leqembi as "unconscionable" and called on the Health and Human Services Department to take action to reduce its cost.